<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03268941</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-906-1002</org_study_id>
    <secondary_id>U1111-1196-9143</secondary_id>
    <nct_id>NCT03268941</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) for TAK-906 in Participants With Diabetes Mellitus and Gastroparesis (DG) or With Idiopathic Gastroparesis (IG)</brief_title>
  <official_title>A 2-Part, Randomized, Double Blind and Open-Label, Placebo and Active-Comparator Controlled Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics for TAK-906 in Subjects With Diabetes Mellitus and Gastroparesis or With Idiopathic Gastroparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Millennium Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety, PK and PD of TAK-906 in participants&#xD;
      with Gastroparesis (GP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called TAK-906 maleate. TAK-906 maleate is being&#xD;
      tested to treat people who have DG or IG. This study will assess the safety, tolerability,&#xD;
      PK/PD and food effect of TAK-906 and will determine the effect of TAK-906 on gastric emptying&#xD;
      (GE).&#xD;
&#xD;
      The study enrolled a total of 51 participants. This study will be conducted in two parts:&#xD;
      Part 1 and Part 2. Part 1 will consist of 48 participants enrolled in 3 active treatment&#xD;
      groups and 1 placebo group. Participants in Part 1 will be randomly assigned (by chance, like&#xD;
      flipping a coin) to one of the 3 active treatment groups or 1 placebo group-which will remain&#xD;
      undisclosed to the participant and study doctor during the study (unless there is an urgent&#xD;
      medical need):&#xD;
&#xD;
        -  TAK 906 maleate 5 mg&#xD;
&#xD;
        -  TAK 906 maleate 25 mg&#xD;
&#xD;
        -  TAK 906 maleate 100 mg&#xD;
&#xD;
        -  Placebo&#xD;
&#xD;
      All participants who will complete Part 1 of the study will be eligible for enrollment in&#xD;
      Part 2. Part 2 consisted of 21 participants who completed Part 1 and were assigned to the 2&#xD;
      open-label treatment groups as follow:&#xD;
&#xD;
        -  TAK-906 maleate 25 mg Fed + TAK-906 maleate 25 mg Fasted: crossover design, with a&#xD;
           minimum 7-day washout in doses of each period.&#xD;
&#xD;
        -  Metoclopramide 10 mg&#xD;
&#xD;
      This multi-center trial will be conducted the United States. The overall time to participate&#xD;
      in this study is approximately 8 weeks. Participants will make a final visit to the clinic&#xD;
      10-14 days after receiving their last dose of study drug for a follow-up assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">March 9, 2018</completion_date>
  <primary_completion_date type="Actual">March 9, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>The study has two parts: Part 1 (double-blind) and Part 2 (open-label).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Experienced At Least One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)</time_frame>
    <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any following reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Markedly Abnormal Laboratory Parameters Values</measure>
    <time_frame>From Baseline to 14 days after the last dose of study drug in Part 1 (Up to approximately 23 days)</time_frame>
    <description>Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as:alanine aminotransferase (ALT)&gt;3.0 U/L*upper limit of normal(ULN),albumin&lt;25 g/L*lower limit of normal(LLN),alkaline phosphatase &gt;3.0 U/L*ULN,aspartate aminotransferase &gt;3.0 U/L*ULN,bilirubin &gt;2 umol/L*ULN,blood urea nitrogen(BUN) &gt;10.7 mmol/L,calcium &lt;1.75 mmol/L, &gt;2.88 mmol/L,chloride &lt;75 mmol/L, &gt;126 mmol/L,creatinine &gt;177umol/L,gamma glutamyl transferase (GGT) &gt;3 U/L*ULN,glucose &lt;2.8 mmol/L, &gt;19.4 mmol/L,phosphate &lt;0.52 mmol/L, &gt;2.10 mmol/L,potassium&lt;3 mmol/L, &gt;6 mmol/L,sodium &lt;130 mmol/L, &gt;150 mmol/L,hematocrit (%) &lt;0.8*LLN, &gt;1.2*ULN,hemoglobin &lt;0.8 g/L*LLN, &gt;1.2 g/L*ULN,leukocytes &lt;0.5 (10^9/L)*LLN, &gt;1.5 (10^9/L)*ULN,erythrocytes&lt;0.8 (10^12/L)*LLN, &gt;1.2(10^12/L)*ULN,platelets &lt;75(10^9/L), &gt;600(10^9/L). Participants with at least 1 markedly abnormal laboratory parameter value is reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Markedly Abnormal Vital Signs</measure>
    <time_frame>From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)</time_frame>
    <description>Vital signs included body temperature, diastolic and systolic blood pressure (mmHg), and heart rate (beats per minute [bpm]). Heart rate&lt;50 bpm and systolic blood pressure &lt;85 mmHg were considered markedly abnormal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values</measure>
    <time_frame>From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)</time_frame>
    <description>The 12-lead electrocardiogram (ECG) values outside the range Heart Rate &lt;50 (beats/min), PR Interval ≤120 (msec), PR Interval ≥200 (msec), QRS Duration ≥120 (msec), QT Interval ≥460 (msec) were considered markedly abnormal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Prolactin Concentration on Day 1 at Tmax, Time of First Occurrence of Maximum Serum Concentration (Cmax) for TAK-906 Maleate for Part 1</measure>
    <time_frame>Day 1 predose (Baseline), 1 hour and at multiple timepoints (Up to 8 hours) postdose</time_frame>
    <description>Change in serum prolactin on Day 1 at the Tmax, time of first occurrence of maximum serum concentration (Cmax) relative to Baseline was calculated as a ratio of maximum serum prolactin concentration on Day 1 to serum prolactin concentration at Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time as Measured by the 13C Spirulina GEBT Following Multiple Dose Administration of TAK-906 Maleate on Day 7 for Part 1</measure>
    <time_frame>Baseline and Day 7</time_frame>
    <description>The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time Following Single Dose Administration of TAK-906 Maleate as Measured by the 13C Spirulina GEBT on Day 1</measure>
    <time_frame>Baseline and Day 1 of Part 1</time_frame>
    <description>The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Gastric Emptying (GE) Time as Measured by the SmartPill on Day 7 for Part 1</measure>
    <time_frame>Baseline and Day 7</time_frame>
    <description>SmartPill is an ingestible capsule that measures pressure, potential of hydrogen (pH) and temperature as it travels through the gastrointestinal (GI) tract to assess GE and GI motility. SmartPill eliminates radiation exposure and is the only motility test that provides a complete transit profile of the GI tract.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCτ: Area Under the Plasma Concentration-time Curve From 0 to Time (T) Over the Dosing Interval for TAK-906 in Part 1</measure>
    <time_frame>Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax: Maximum Observed Plasma Concentration for TAK 906 in Part 1</measure>
    <time_frame>Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1</measure>
    <time_frame>Part 1: Predose on Days 2, 3, 4, 5, 6, 7, 8 and 9</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 in Part 1</measure>
    <time_frame>Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose</time_frame>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Diabetes Mellitus and Gastroparesis, Idiopathic Gastroparesis</condition>
  <arm_group>
    <arm_group_label>Part 1: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: TAK 906 Maleate 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: TAK 906 Maleate 25 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: TAK 906 Maleate 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: TAK-906 Maleate 25 mg Fed Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (high fat breakfast), followed by a minimum 7- day washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: TAK-906 Maleate 25 mg Fasted Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Metoclopramide 10 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-906 Maleate</intervention_name>
    <description>TAK-906 Maleate Capsules</description>
    <arm_group_label>Part 1: TAK 906 Maleate 100 mg</arm_group_label>
    <arm_group_label>Part 1: TAK 906 Maleate 25 mg</arm_group_label>
    <arm_group_label>Part 1: TAK 906 Maleate 5 mg</arm_group_label>
    <arm_group_label>Part 2: TAK-906 Maleate 25 mg Fasted Condition</arm_group_label>
    <arm_group_label>Part 2: TAK-906 Maleate 25 mg Fed Condition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metaclopramide</intervention_name>
    <description>Metaclopramide Tablets</description>
    <arm_group_label>Part 2: Metoclopramide 10 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-906 Maleate Placebo</intervention_name>
    <description>TAK-906 placebo-matching Capsules</description>
    <arm_group_label>Part 1: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        In order to be eligible for participation in this trial, the participant must:&#xD;
&#xD;
          1. Has a documented diagnosis of diabetes mellitus gastroparesis (DG) or idiopathic&#xD;
             gastroparesis (IG).&#xD;
&#xD;
          2. Has a body mass index (BMI) greater than or equal to (&gt;=) 18 and less than or equal to&#xD;
             (&lt;=) 40 kilogram per square meter (kg/m^2) at the Screening Visit.&#xD;
&#xD;
          3. Be a non-smoker who has not used tobacco or nicotine-containing products (example,&#xD;
             nicotine patch) for at least 6 months prior to trial drug administration of the&#xD;
             initial dose of trial drug/invasive procedure.&#xD;
&#xD;
          4. Has symptoms for gastroparesis (GP) (that is, chronic postprandial fullness, abdominal&#xD;
             pain, postprandial nausea, vomiting, loss of appetite and/or early satiety) the past 3&#xD;
             months.&#xD;
&#xD;
          5. Has documented slow gastric emptying (GE), with delayed GE by 13C-Spirulina gastric&#xD;
             emptying breath test (GEBT) at Screening defined as &gt;=80th percentile. Note: If a&#xD;
             participant has had a documented scintigraphy or GEBT within the last 12 months that&#xD;
             confirms the diagnosis of delayed GE, a screening GEBT would not be required.&#xD;
&#xD;
          6. Has nausea subscale (of American Neurogastroenterology and Motility Society&#xD;
             Gastroparesis Cardinal Symptom Index-Daily Diary [ANMS-GCSI-DD]) symptom score &gt;=2 at&#xD;
             least 3 of 7 days during Screening.&#xD;
&#xD;
          7. Has haemoglobin A1c (HBA1c) less than (&lt;) 10 percent (%) (for diabetes mellitus only).&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        The participant must be excluded from participating in the trial if the participant:&#xD;
&#xD;
          1. Has acute severe gastroenteritis and pronounced dehydration in the past 48 hours prior&#xD;
             to Screening, gastric pacemaker, chronic parenteral feeding or persistent severe&#xD;
             vomiting.&#xD;
&#xD;
          2. Has a known disturbance of small intestinal absorption, exocrine pancreatic function,&#xD;
             liver metabolism, and pulmonary function.&#xD;
&#xD;
          3. Has a history of anorexia nervosa or bulimia.&#xD;
&#xD;
          4. Previous history of bezoars (the presence of retained liquid, bile, or small amounts&#xD;
             of poorly organized food residue is permitted).&#xD;
&#xD;
          5. Difficulty swallowing solid food or pills.&#xD;
&#xD;
          6. Prior surgery involving the luminal gastrointestinal (GI) tract (cholecystectomy,&#xD;
             appendectomy, and hysterectomy are permitted if performed greater than (&gt;) 3 months&#xD;
             prior to SmartPill test).&#xD;
&#xD;
          7. Any abdominal or pelvic surgery within the past 3 months.&#xD;
&#xD;
          8. Known or history of inflammatory bowel disease.&#xD;
&#xD;
          9. Has active diverticulitis, diverticular stricture, and other intestinal strictures.&#xD;
&#xD;
         10. Had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter [mL])&#xD;
             within 4 weeks prior to the pretrial (screening) visit milligram per deciliter (mg/dL)&#xD;
             (14.99 millimole per liter [mmol/L]) during any visit up to and including the&#xD;
             randomization visit (Period 1 Day 1 predose). Note: If the participant meets this&#xD;
             exclusion criterion and the investigator believes that the value is not consistent&#xD;
             with the participant's current self-monitoring blood glucose values, the participant&#xD;
             should not be excluded at this time. The visit can be repeated within 5 to 7 days.&#xD;
&#xD;
         11. Has had diabetic ketoacidosis (within the prior 4 weeks).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Millennium Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>9171 West Thunderbird Road</name>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <zip>85381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>850 North Kolb Road</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>11219 Financial Centre Parkway</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>13055 Southwest 42nd Street</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>8200 Southwest 117th Avenue</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33183</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>125 Clairemont Avenue</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>616 South Washington Street</name>
      <address>
        <city>Bastrop</city>
        <state>Louisiana</state>
        <zip>71220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>6035 Shallowford Road</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>26 Stonecreek Circle</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <results_first_submitted>May 16, 2019</results_first_submitted>
  <results_first_submitted_qc>July 3, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 23, 2019</results_first_posted>
  <last_update_submitted>December 16, 2020</last_update_submitted>
  <last_update_submitted_qc>December 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metoclopramide</mesh_term>
    <mesh_term>Maleic acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03268941/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03268941/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 7 investigative sites in the United States from 26 September 2017 to 09 March 2018.</recruitment_details>
      <pre_assignment_details>Participants with a diagnosis of diabetes mellitus and gastroparesis (GP) or with idiopathic gastroparesis (IG) were enrolled. 51 participants were randomized in Part 1, out of which 48 completed the Part 1, 21 of 48 participants entered the Part 2.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1: Placebo</title>
          <description>TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.</description>
        </group>
        <group group_id="P2">
          <title>Part 1: TAK 906 Maleate 5 mg</title>
          <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
        </group>
        <group group_id="P3">
          <title>Part 1: TAK 906 Maleate 25 mg</title>
          <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
        </group>
        <group group_id="P4">
          <title>Part 1: TAK 906 Maleate 100 mg</title>
          <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
        </group>
        <group group_id="P5">
          <title>Part 2: TAK-906 Maleate 25 mg Under Fed Conditions</title>
          <description>TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) followed by fasted condition. There was a minimum 7- day washout period between the two conditions.</description>
        </group>
        <group group_id="P6">
          <title>Part 2: TAK-906 Maleate 25 mg Fasted Condition</title>
          <description>TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.</description>
        </group>
        <group group_id="P7">
          <title>Part 2: Metoclopramide 10 mg</title>
          <description>Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part 1 (Days 1 to 9)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="13"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 2: Days 17 to 25</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Reason not specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 2: Period 2: Fasted (Day 25)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis set (SAS), Part 1, included all participants who were randomized (Part 1) and received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Part 1: Placebo</title>
          <description>TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.</description>
        </group>
        <group group_id="B2">
          <title>Part 1: TAK 906 Maleate 5 mg</title>
          <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
        </group>
        <group group_id="B3">
          <title>Part 1: TAK 906 Maleate 25 mg</title>
          <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
        </group>
        <group group_id="B4">
          <title>Part 1: TAK 906 Maleate 100 mg</title>
          <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="14"/>
            <count group_id="B3" value="12"/>
            <count group_id="B4" value="13"/>
            <count group_id="B5" value="51"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.9" spread="13.84"/>
                    <measurement group_id="B2" value="54.7" spread="11.75"/>
                    <measurement group_id="B3" value="52.7" spread="17.13"/>
                    <measurement group_id="B4" value="55.9" spread="10.19"/>
                    <measurement group_id="B5" value="53.4" spread="13.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-Hispanic and Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiracial</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="164.62" spread="9.790"/>
                    <measurement group_id="B2" value="163.95" spread="6.751"/>
                    <measurement group_id="B3" value="164.56" spread="7.204"/>
                    <measurement group_id="B4" value="164.93" spread="9.778"/>
                    <measurement group_id="B5" value="164.50" spread="8.212"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.70" spread="17.231"/>
                    <measurement group_id="B2" value="79.86" spread="13.470"/>
                    <measurement group_id="B3" value="80.55" spread="11.346"/>
                    <measurement group_id="B4" value="88.24" spread="11.803"/>
                    <measurement group_id="B5" value="80.95" spread="14.064"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>Body Mass Index = weight/[height^2]</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.282" spread="4.2276"/>
                    <measurement group_id="B2" value="29.679" spread="4.5043"/>
                    <measurement group_id="B3" value="29.832" spread="4.5461"/>
                    <measurement group_id="B4" value="32.565" spread="4.4001"/>
                    <measurement group_id="B5" value="29.887" spread="4.6805"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Underlying Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Diabetic Gastroparesis (DG)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Idiopathic Gastroparesis (IG)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced At Least One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
        <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any following reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.</description>
        <time_frame>From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)</time_frame>
        <population>SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: TAK 906 Maleate 5 mg</title>
            <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: TAK 906 Maleate 25 mg</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: TAK 906 Maleate 100 mg</title>
            <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O5">
            <title>Part 2: TAK-906 Maleate 25 mg Fed Condition</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.</description>
          </group>
          <group group_id="O6">
            <title>Part 2: TAK-906 Maleate 25 mg Fasted Condition</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.</description>
          </group>
          <group group_id="O7">
            <title>Part 2: Metoclopramide 10 mg</title>
            <description>Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced At Least One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
          <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any following reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.</description>
          <population>SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Markedly Abnormal Laboratory Parameters Values</title>
        <description>Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as:alanine aminotransferase (ALT)&gt;3.0 U/L*upper limit of normal(ULN),albumin&lt;25 g/L*lower limit of normal(LLN),alkaline phosphatase &gt;3.0 U/L*ULN,aspartate aminotransferase &gt;3.0 U/L*ULN,bilirubin &gt;2 umol/L*ULN,blood urea nitrogen(BUN) &gt;10.7 mmol/L,calcium &lt;1.75 mmol/L, &gt;2.88 mmol/L,chloride &lt;75 mmol/L, &gt;126 mmol/L,creatinine &gt;177umol/L,gamma glutamyl transferase (GGT) &gt;3 U/L*ULN,glucose &lt;2.8 mmol/L, &gt;19.4 mmol/L,phosphate &lt;0.52 mmol/L, &gt;2.10 mmol/L,potassium&lt;3 mmol/L, &gt;6 mmol/L,sodium &lt;130 mmol/L, &gt;150 mmol/L,hematocrit (%) &lt;0.8*LLN, &gt;1.2*ULN,hemoglobin &lt;0.8 g/L*LLN, &gt;1.2 g/L*ULN,leukocytes &lt;0.5 (10^9/L)*LLN, &gt;1.5 (10^9/L)*ULN,erythrocytes&lt;0.8 (10^12/L)*LLN, &gt;1.2(10^12/L)*ULN,platelets &lt;75(10^9/L), &gt;600(10^9/L). Participants with at least 1 markedly abnormal laboratory parameter value is reported.</description>
        <time_frame>From Baseline to 14 days after the last dose of study drug in Part 1 (Up to approximately 23 days)</time_frame>
        <population>SAS included all participants who were randomized and received at least 1 dose of study drug in the Part 1. Laboratory assessment were performed only in Part 1 of the study. Number analyzed are participants with data available for the particular parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: TAK 906 Maleate 5 mg</title>
            <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: TAK 906 Maleate 25 mg</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: TAK 906 Maleate 100 mg</title>
            <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Markedly Abnormal Laboratory Parameters Values</title>
          <description>Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as:alanine aminotransferase (ALT)&gt;3.0 U/L*upper limit of normal(ULN),albumin&lt;25 g/L*lower limit of normal(LLN),alkaline phosphatase &gt;3.0 U/L*ULN,aspartate aminotransferase &gt;3.0 U/L*ULN,bilirubin &gt;2 umol/L*ULN,blood urea nitrogen(BUN) &gt;10.7 mmol/L,calcium &lt;1.75 mmol/L, &gt;2.88 mmol/L,chloride &lt;75 mmol/L, &gt;126 mmol/L,creatinine &gt;177umol/L,gamma glutamyl transferase (GGT) &gt;3 U/L*ULN,glucose &lt;2.8 mmol/L, &gt;19.4 mmol/L,phosphate &lt;0.52 mmol/L, &gt;2.10 mmol/L,potassium&lt;3 mmol/L, &gt;6 mmol/L,sodium &lt;130 mmol/L, &gt;150 mmol/L,hematocrit (%) &lt;0.8*LLN, &gt;1.2*ULN,hemoglobin &lt;0.8 g/L*LLN, &gt;1.2 g/L*ULN,leukocytes &lt;0.5 (10^9/L)*LLN, &gt;1.5 (10^9/L)*ULN,erythrocytes&lt;0.8 (10^12/L)*LLN, &gt;1.2(10^12/L)*ULN,platelets &lt;75(10^9/L), &gt;600(10^9/L). Participants with at least 1 markedly abnormal laboratory parameter value is reported.</description>
          <population>SAS included all participants who were randomized and received at least 1 dose of study drug in the Part 1. Laboratory assessment were performed only in Part 1 of the study. Number analyzed are participants with data available for the particular parameter.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematocrit (%)&lt;0.8 x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin (g/L) &lt;0.8 x LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT &gt;3.0 U/Lx ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST &gt;3.0 U/L x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BUN &gt;10.7 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium &gt;2.88 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT &gt;3 x ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium (mmol/L) &lt;130 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Markedly Abnormal Vital Signs</title>
        <description>Vital signs included body temperature, diastolic and systolic blood pressure (mmHg), and heart rate (beats per minute [bpm]). Heart rate&lt;50 bpm and systolic blood pressure &lt;85 mmHg were considered markedly abnormal.</description>
        <time_frame>From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)</time_frame>
        <population>SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: TAK 906 Maleate 5 mg</title>
            <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: TAK 906 Maleate 25 mg</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: TAK 906 Maleate 100 mg</title>
            <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O5">
            <title>Part 2: TAK-906 Maleate 25 mg Fed Condition</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.</description>
          </group>
          <group group_id="O6">
            <title>Part 2: TAK-906 Maleate 25 mg Fasted Condition</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.</description>
          </group>
          <group group_id="O7">
            <title>Part 2: Metoclopramide 10 mg</title>
            <description>Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Markedly Abnormal Vital Signs</title>
          <description>Vital signs included body temperature, diastolic and systolic blood pressure (mmHg), and heart rate (beats per minute [bpm]). Heart rate&lt;50 bpm and systolic blood pressure &lt;85 mmHg were considered markedly abnormal.</description>
          <population>SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Heart Rate (bpm) &lt;50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure (mmHg) &lt;85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values</title>
        <description>The 12-lead electrocardiogram (ECG) values outside the range Heart Rate &lt;50 (beats/min), PR Interval ≤120 (msec), PR Interval ≥200 (msec), QRS Duration ≥120 (msec), QT Interval ≥460 (msec) were considered markedly abnormal.</description>
        <time_frame>From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)</time_frame>
        <population>SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: TAK 906 Maleate 5 mg</title>
            <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: TAK 906 Maleate 25 mg</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: TAK 906 Maleate 100 mg</title>
            <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O5">
            <title>Part 2: TAK-906 Maleate 25 mg Fed Condition</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.</description>
          </group>
          <group group_id="O6">
            <title>Part 2: TAK-906 Maleate 25 mg Fasted Condition</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.</description>
          </group>
          <group group_id="O7">
            <title>Part 2: Metoclopramide 10 mg</title>
            <description>Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values</title>
          <description>The 12-lead electrocardiogram (ECG) values outside the range Heart Rate &lt;50 (beats/min), PR Interval ≤120 (msec), PR Interval ≥200 (msec), QRS Duration ≥120 (msec), QT Interval ≥460 (msec) were considered markedly abnormal.</description>
          <population>SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Heart Rate (bpm) &lt;50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR Interval (msec) ≤120</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR Interval (msec) ≥200</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration (msec) ≥120</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT Interval (msec) ≥460</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Prolactin Concentration on Day 1 at Tmax, Time of First Occurrence of Maximum Serum Concentration (Cmax) for TAK-906 Maleate for Part 1</title>
        <description>Change in serum prolactin on Day 1 at the Tmax, time of first occurrence of maximum serum concentration (Cmax) relative to Baseline was calculated as a ratio of maximum serum prolactin concentration on Day 1 to serum prolactin concentration at Baseline.</description>
        <time_frame>Day 1 predose (Baseline), 1 hour and at multiple timepoints (Up to 8 hours) postdose</time_frame>
        <population>Full analysis set (FAS) included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for at least one of pharmacodynamic (PD) measurement. Overall number of participants analyzed are participants with evaluable data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: TAK 906 Maleate 5 mg</title>
            <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: TAK 906 Maleate 25 mg</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: TAK 906 Maleate 100 mg</title>
            <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Prolactin Concentration on Day 1 at Tmax, Time of First Occurrence of Maximum Serum Concentration (Cmax) for TAK-906 Maleate for Part 1</title>
          <description>Change in serum prolactin on Day 1 at the Tmax, time of first occurrence of maximum serum concentration (Cmax) relative to Baseline was calculated as a ratio of maximum serum prolactin concentration on Day 1 to serum prolactin concentration at Baseline.</description>
          <population>Full analysis set (FAS) included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for at least one of pharmacodynamic (PD) measurement. Overall number of participants analyzed are participants with evaluable data for this outcome measure.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.54" spread="0.704"/>
                    <measurement group_id="O2" value="12.77" spread="9.102"/>
                    <measurement group_id="O3" value="19.92" spread="13.604"/>
                    <measurement group_id="O4" value="20.07" spread="9.170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Least Square (LS) Mean Difference</param_type>
            <param_value>7.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.03</ci_lower_limit>
            <ci_upper_limit>13.52</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>11.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.91</ci_lower_limit>
            <ci_upper_limit>21.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration - covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>12.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.94</ci_lower_limit>
            <ci_upper_limit>23.59</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time as Measured by the 13C Spirulina GEBT Following Multiple Dose Administration of TAK-906 Maleate on Day 7 for Part 1</title>
        <description>The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.</description>
        <time_frame>Baseline and Day 7</time_frame>
        <population>FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for assessment of at least one of the PD measurement. Overall number of participants analyzed are the participants with evaluable data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: TAK 906 Maleate 5 mg</title>
            <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: TAK 906 Maleate 25 mg</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: TAK 906 Maleate 100 mg</title>
            <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time as Measured by the 13C Spirulina GEBT Following Multiple Dose Administration of TAK-906 Maleate on Day 7 for Part 1</title>
          <description>The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.</description>
          <population>FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for assessment of at least one of the PD measurement. Overall number of participants analyzed are the participants with evaluable data for this outcome measure.</population>
          <units>min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.74" spread="43.106"/>
                    <measurement group_id="O2" value="130.18" spread="35.316"/>
                    <measurement group_id="O3" value="121.26" spread="33.606"/>
                    <measurement group_id="O4" value="122.50" spread="31.803"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.55" spread="16.332"/>
                    <measurement group_id="O2" value="6.21" spread="36.986"/>
                    <measurement group_id="O3" value="7.80" spread="52.946"/>
                    <measurement group_id="O4" value="7.72" spread="24.609"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.599</p_value>
            <p_value_desc>P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>7.76</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>14.648</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.89</ci_lower_limit>
            <ci_upper_limit>37.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.687</p_value>
            <p_value_desc>P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>6.28</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>15.469</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.04</ci_lower_limit>
            <ci_upper_limit>37.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.605</p_value>
            <p_value_desc>P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>8.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>15.450</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.22</ci_lower_limit>
            <ci_upper_limit>39.33</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time Following Single Dose Administration of TAK-906 Maleate as Measured by the 13C Spirulina GEBT on Day 1</title>
        <description>The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.</description>
        <time_frame>Baseline and Day 1 of Part 1</time_frame>
        <population>FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline at least 1 valid postbaseline value for assessment of at least one PD measurement. Overall number of participants analyzed are participants with evaluable data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: TAK 906 Maleate 5 mg</title>
            <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: TAK 906 Maleate 25 mg</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: TAK 906 Maleate 100 mg</title>
            <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time Following Single Dose Administration of TAK-906 Maleate as Measured by the 13C Spirulina GEBT on Day 1</title>
          <description>The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.</description>
          <population>FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline at least 1 valid postbaseline value for assessment of at least one PD measurement. Overall number of participants analyzed are participants with evaluable data for this outcome measure.</population>
          <units>minute (min)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.74" spread="43.106"/>
                    <measurement group_id="O2" value="130.18" spread="35.316"/>
                    <measurement group_id="O3" value="121.26" spread="33.606"/>
                    <measurement group_id="O4" value="122.50" spread="31.803"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.71" spread="21.687"/>
                    <measurement group_id="O2" value="0.12" spread="21.736"/>
                    <measurement group_id="O3" value="6.74" spread="44.390"/>
                    <measurement group_id="O4" value="0.71" spread="21.192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.522</p_value>
            <p_value_desc>P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>7.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>11.708</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.06</ci_lower_limit>
            <ci_upper_limit>31.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.293</p_value>
            <p_value_desc>P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>12.92</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>12.143</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.58</ci_lower_limit>
            <ci_upper_limit>37.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.551</p_value>
            <p_value_desc>P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>7.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>11.654</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.52</ci_lower_limit>
            <ci_upper_limit>30.52</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Gastric Emptying (GE) Time as Measured by the SmartPill on Day 7 for Part 1</title>
        <description>SmartPill is an ingestible capsule that measures pressure, potential of hydrogen (pH) and temperature as it travels through the gastrointestinal (GI) tract to assess GE and GI motility. SmartPill eliminates radiation exposure and is the only motility test that provides a complete transit profile of the GI tract.</description>
        <time_frame>Baseline and Day 7</time_frame>
        <population>FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for assessment of at least one of the PD measurements. Overall number of participants analyzed is number of participants with evaluable data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: Placebo</title>
            <description>TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: TAK 906 Maleate 5 mg</title>
            <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: TAK 906 Maleate 25 mg</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: TAK 906 Maleate 100 mg</title>
            <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Gastric Emptying (GE) Time as Measured by the SmartPill on Day 7 for Part 1</title>
          <description>SmartPill is an ingestible capsule that measures pressure, potential of hydrogen (pH) and temperature as it travels through the gastrointestinal (GI) tract to assess GE and GI motility. SmartPill eliminates radiation exposure and is the only motility test that provides a complete transit profile of the GI tract.</description>
          <population>FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for assessment of at least one of the PD measurements. Overall number of participants analyzed is number of participants with evaluable data for this outcome measure.</population>
          <units>percent change in GE time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124.62" spread="181.125"/>
                    <measurement group_id="O2" value="61.72" spread="195.867"/>
                    <measurement group_id="O3" value="419.27" spread="885.362"/>
                    <measurement group_id="O4" value="71.09" spread="121.584"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.274</p_value>
            <p_value_desc>P-value was obtained with pairwise Wilcoxon Rank Sum tests.</p_value_desc>
            <method>Wilcoxon Rank Sum tests</method>
            <param_type>Hodges-Lehmann Estimate of Median Diff</param_type>
            <param_value>-18.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-307.58</ci_lower_limit>
            <ci_upper_limit>13.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.481</p_value>
            <p_value_desc>P-value was obtained with pairwise Wilcoxon Rank Sum tests.</p_value_desc>
            <method>Wilcoxon Rank Sum tests</method>
            <param_type>Hodges-Lehmann Estimate of Median Diff</param_type>
            <param_value>-26.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-229.73</ci_lower_limit>
            <ci_upper_limit>530.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Percent Change in GE on time measured by the SmartPill Day 7 in Part 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.382</p_value>
            <p_value_desc>P-value was obtained with pairwise Wilcoxon Rank Sum tests.</p_value_desc>
            <method>Wilcoxon Rank Sum tests</method>
            <param_type>Hodges-Lehmann Estimate of Median Diff</param_type>
            <param_value>-24.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-225.87</ci_lower_limit>
            <ci_upper_limit>98.91</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUCτ: Area Under the Plasma Concentration-time Curve From 0 to Time (T) Over the Dosing Interval for TAK-906 in Part 1</title>
        <time_frame>Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose</time_frame>
        <population>Pharmacokinetic (PK) set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of AUCt. Number analyzed are participants with evaluable data at given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: TAK 906 Maleate 5 mg</title>
            <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: TAK 906 Maleate 25 mg</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: TAK 906 Maleate 100 mg</title>
            <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>AUCτ: Area Under the Plasma Concentration-time Curve From 0 to Time (T) Over the Dosing Interval for TAK-906 in Part 1</title>
          <population>Pharmacokinetic (PK) set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of AUCt. Number analyzed are participants with evaluable data at given time-point.</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.67" spread="1.69"/>
                    <measurement group_id="O2" value="23.0" spread="7.76"/>
                    <measurement group_id="O3" value="131" spread="44.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.46" spread="2.07"/>
                    <measurement group_id="O2" value="26.3" spread="11.3"/>
                    <measurement group_id="O3" value="166" spread="93.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax: Maximum Observed Plasma Concentration for TAK 906 in Part 1</title>
        <time_frame>Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose</time_frame>
        <population>PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Cmax. Number analyzed are participants with evaluable data at given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: TAK 906 Maleate 5 mg</title>
            <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: TAK 906 Maleate 25 mg</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: TAK 906 Maleate 100 mg</title>
            <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax: Maximum Observed Plasma Concentration for TAK 906 in Part 1</title>
          <population>PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Cmax. Number analyzed are participants with evaluable data at given time-point.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.27" spread="0.819"/>
                    <measurement group_id="O2" value="12.0" spread="5.36"/>
                    <measurement group_id="O3" value="75.7" spread="39.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.87" spread="1.78"/>
                    <measurement group_id="O2" value="15.5" spread="5.58"/>
                    <measurement group_id="O3" value="99.6" spread="69.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1</title>
        <time_frame>Part 1: Predose on Days 2, 3, 4, 5, 6, 7, 8 and 9</time_frame>
        <population>PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Ctrough. Number analyzed are participants with evaluable data at given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: TAK 906 Maleate 5 mg</title>
            <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: TAK 906 Maleate 25 mg</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: TAK 906 Maleate 100 mg</title>
            <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1</title>
          <population>PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Ctrough. Number analyzed are participants with evaluable data at given time-point.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Predose on Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0121" spread="0.0315"/>
                    <measurement group_id="O2" value="0.262" spread="0.349"/>
                    <measurement group_id="O3" value="0.770" spread="0.513"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Predose on Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0423" spread="0.0527"/>
                    <measurement group_id="O2" value="0.503" spread="0.640"/>
                    <measurement group_id="O3" value="0.958" spread="0.750"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Predose on Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0178" spread="0.0503"/>
                    <measurement group_id="O2" value="0.302" spread="0.214"/>
                    <measurement group_id="O3" value="1.17" spread="0.799"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Predose on Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0457" spread="0.0962"/>
                    <measurement group_id="O2" value="1.09" spread="1.97"/>
                    <measurement group_id="O3" value="1.95" spread="2.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Predose on Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0423" spread="0.0502"/>
                    <measurement group_id="O2" value="0.412" spread="0.415"/>
                    <measurement group_id="O3" value="1.01" spread="0.469"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Predose on Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0596" spread="0.0905"/>
                    <measurement group_id="O2" value="0.336" spread="0.383"/>
                    <measurement group_id="O3" value="1.48" spread="0.936"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Predose on Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0763" spread="0.100"/>
                    <measurement group_id="O2" value="0.522" spread="0.648"/>
                    <measurement group_id="O3" value="1.16" spread="0.878"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Predose on Day 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0700" spread="0.120"/>
                    <measurement group_id="O2" value="0.280" spread="0.243"/>
                    <measurement group_id="O3" value="1.40" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 in Part 1</title>
        <time_frame>Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose</time_frame>
        <population>PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Tmax. Number analyzed are participants with evaluable data at given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: TAK 906 Maleate 5 mg</title>
            <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: TAK 906 Maleate 25 mg</title>
            <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: TAK 906 Maleate 100 mg</title>
            <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 in Part 1</title>
          <population>PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Tmax. Number analyzed are participants with evaluable data at given time-point.</population>
          <units>hour (hr)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="0.48" upper_limit="2.00"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.50" upper_limit="4.00"/>
                    <measurement group_id="O3" value="1.00" lower_limit="0.50" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="0.50" upper_limit="2.00"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.50" upper_limit="1.52"/>
                    <measurement group_id="O3" value="0.98" lower_limit="0.48" upper_limit="1.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)</time_frame>
      <desc>Collection of AEs was commenced at the time the subject signed the informed consent and continued until 14 days after the last dose of investigational product. At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part 1: Placebo</title>
          <description>TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.</description>
        </group>
        <group group_id="E2">
          <title>Part 1: TAK 906 Maleate 5 mg</title>
          <description>TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.</description>
        </group>
        <group group_id="E3">
          <title>Part 1: TAK 906 Maleate 25 mg</title>
          <description>TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.</description>
        </group>
        <group group_id="E4">
          <title>Part 1: TAK 906 Maleate 100 mg</title>
          <description>TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.</description>
        </group>
        <group group_id="E5">
          <title>Part 2: TAK-906 Maleate 25 mg Fed Condition</title>
          <description>TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed (high fat breakfast) conditions followed by minimum 7- day washout period.</description>
        </group>
        <group group_id="E6">
          <title>Part 2: TAK-906 Maleate 25 mg Fasted Condition</title>
          <description>TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.</description>
        </group>
        <group group_id="E7">
          <title>Part 2: Metoclopramide 10 mg</title>
          <description>Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2. There was a minimum 7- day washout period between the two conditions.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <description>Participant in Part 1: TAK 906 Maleate 100 mg had an AE of liver function test increased on Day 1. The blood draw for the liver function tests was done prior to the first study drug administration.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <description>A mild AE of tremor occurred in 1 participant (had history of diabetes) in Part 1:TAK 906 Maleate 100 mg arm, on Day 3, resolved on Day 4, considered not related by investigator. No other signs/symptoms of neurological origin were observed.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>trialdisclosures@takeda.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03268941
org study id: TAK-906-1002
secondary id: U1111-1196-9143
nct id: NCT03268941
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the safety, PK and PD of TAK-906 in participants
      with Gastroparesis (GP).
The drug being tested in this study is called TAK-906 maleate. TAK-906 maleate is being
      tested to treat people who have DG or IG. This study will assess the safety, tolerability,
      PK/PD and food effect of TAK-906 and will determine the effect of TAK-906 on gastric emptying
      (GE).

      The study enrolled a total of 51 participants. This study will be conducted in two parts:
      Part 1 and Part 2. Part 1 will consist of 48 participants enrolled in 3 active treatment
      groups and 1 placebo group. Participants in Part 1 will be randomly assigned (by chance, like
      flipping a coin) to one of the 3 active treatment groups or 1 placebo group-which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need):

        -  TAK 906 maleate 5 mg

        -  TAK 906 maleate 25 mg

        -  TAK 906 maleate 100 mg

        -  Placebo

      All participants who will complete Part 1 of the study will be eligible for enrollment in
      Part 2. Part 2 consisted of 21 participants who completed Part 1 and were assigned to the 2
      open-label treatment groups as follow:

        -  TAK-906 maleate 25 mg Fed + TAK-906 maleate 25 mg Fasted: crossover design, with a
           minimum 7-day washout in doses of each period.

        -  Metoclopramide 10 mg

      This multi-center trial will be conducted the United States. The overall time to participate
      in this study is approximately 8 weeks. Participants will make a final visit to the clinic
      10-14 days after receiving their last dose of study drug for a follow-up assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
masking description: The study has two parts: Part 1 (double-blind) and Part 2 (open-label).
measure: Number of Participants Who Experienced At Least One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
time frame: From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
description: An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any following reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
measure: Number of Participants With Markedly Abnormal Laboratory Parameters Values
time frame: From Baseline to 14 days after the last dose of study drug in Part 1 (Up to approximately 23 days)
description: Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as:alanine aminotransferase (ALT)>3.0 U/L*upper limit of normal(ULN),albumin<25 g/L*lower limit of normal(LLN),alkaline phosphatase >3.0 U/L*ULN,aspartate aminotransferase >3.0 U/L*ULN,bilirubin >2 umol/L*ULN,blood urea nitrogen(BUN) >10.7 mmol/L,calcium <1.75 mmol/L, >2.88 mmol/L,chloride <75 mmol/L, >126 mmol/L,creatinine >177umol/L,gamma glutamyl transferase (GGT) >3 U/L*ULN,glucose <2.8 mmol/L, >19.4 mmol/L,phosphate <0.52 mmol/L, >2.10 mmol/L,potassium<3 mmol/L, >6 mmol/L,sodium <130 mmol/L, >150 mmol/L,hematocrit (%) <0.8*LLN, >1.2*ULN,hemoglobin <0.8 g/L*LLN, >1.2 g/L*ULN,leukocytes <0.5 (10^9/L)*LLN, >1.5 (10^9/L)*ULN,erythrocytes<0.8 (10^12/L)*LLN, >1.2(10^12/L)*ULN,platelets <75(10^9/L), >600(10^9/L). Participants with at least 1 markedly abnormal laboratory parameter value is reported.
measure: Number of Participants With Markedly Abnormal Vital Signs
time frame: From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
description: Vital signs included body temperature, diastolic and systolic blood pressure (mmHg), and heart rate (beats per minute [bpm]). Heart rate<50 bpm and systolic blood pressure <85 mmHg were considered markedly abnormal.
measure: Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values
time frame: From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)
description: The 12-lead electrocardiogram (ECG) values outside the range Heart Rate <50 (beats/min), PR Interval ≤120 (msec), PR Interval ≥200 (msec), QRS Duration ≥120 (msec), QT Interval ≥460 (msec) were considered markedly abnormal.
measure: Change From Baseline in Serum Prolactin Concentration on Day 1 at Tmax, Time of First Occurrence of Maximum Serum Concentration (Cmax) for TAK-906 Maleate for Part 1
time frame: Day 1 predose (Baseline), 1 hour and at multiple timepoints (Up to 8 hours) postdose
description: Change in serum prolactin on Day 1 at the Tmax, time of first occurrence of maximum serum concentration (Cmax) relative to Baseline was calculated as a ratio of maximum serum prolactin concentration on Day 1 to serum prolactin concentration at Baseline.
measure: Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time as Measured by the 13C Spirulina GEBT Following Multiple Dose Administration of TAK-906 Maleate on Day 7 for Part 1
time frame: Baseline and Day 7
description: The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.
measure: Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time Following Single Dose Administration of TAK-906 Maleate as Measured by the 13C Spirulina GEBT on Day 1
time frame: Baseline and Day 1 of Part 1
description: The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.
measure: Percent Change From Baseline in Gastric Emptying (GE) Time as Measured by the SmartPill on Day 7 for Part 1
time frame: Baseline and Day 7
description: SmartPill is an ingestible capsule that measures pressure, potential of hydrogen (pH) and temperature as it travels through the gastrointestinal (GI) tract to assess GE and GI motility. SmartPill eliminates radiation exposure and is the only motility test that provides a complete transit profile of the GI tract.
measure: AUCτ: Area Under the Plasma Concentration-time Curve From 0 to Time (T) Over the Dosing Interval for TAK-906 in Part 1
time frame: Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose
measure: Cmax: Maximum Observed Plasma Concentration for TAK 906 in Part 1
time frame: Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose
measure: Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1
time frame: Part 1: Predose on Days 2, 3, 4, 5, 6, 7, 8 and 9
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 in Part 1
time frame: Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose
arm group label: Part 1: Placebo
arm group type: Placebo Comparator
description: TAK-906 placebo-matching (4x0 mg), capsule, orally, twice daily (BID) on Days 1-8 and once on Day 9 under fasted conditions.
arm group label: Part 1: TAK 906 Maleate 5 mg
arm group type: Experimental
description: TAK-906 maleate 1x5 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8, followed by TAK-906 maleate 1x5 mg, capsule, orally once on Day 9 under fasted conditions.
arm group label: Part 1: TAK 906 Maleate 25 mg
arm group type: Experimental
description: TAK-906 maleate 1x25 mg, capsule, orally, BID and TAK-906 maleate placebo-matching (3x0 mg), capsules, orally, BID on Days 1-8 followed by TAK-906 maleate 1x25 mg, capsule, orally, once on Day 9 under fasted conditions.
arm group label: Part 1: TAK 906 Maleate 100 mg
arm group type: Experimental
description: TAK-906 maleate 100 mg (4x25 mg), capsules, orally, BID on Days 1-8 and once a day on Day 9 under fasted conditions.
arm group label: Part 2: TAK-906 Maleate 25 mg Fed Condition
arm group type: Experimental
description: TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (high fat breakfast), followed by a minimum 7- day washout.
arm group label: Part 2: TAK-906 Maleate 25 mg Fasted Condition
arm group type: Experimental
description: TAK-906 maleate 1x25 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions.
arm group label: Part 2: Metoclopramide 10 mg
arm group type: Active Comparator
description: Metaclopramide 10 mg, tablet, orally, once, 1 hour prior to breakfast on Day 1 in Part 2.
intervention type: Drug
intervention name: TAK-906 Maleate
description: TAK-906 Maleate Capsules
arm group label: Part 1: TAK 906 Maleate 100 mg
arm group label: Part 1: TAK 906 Maleate 25 mg
arm group label: Part 1: TAK 906 Maleate 5 mg
arm group label: Part 2: TAK-906 Maleate 25 mg Fasted Condition
arm group label: Part 2: TAK-906 Maleate 25 mg Fed Condition
intervention type: Drug
intervention name: Metaclopramide
description: Metaclopramide Tablets
arm group label: Part 2: Metoclopramide 10 mg
intervention type: Drug
intervention name: TAK-906 Maleate Placebo
description: TAK-906 placebo-matching Capsules
arm group label: Part 1: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Millennium Pharmaceuticals, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Gastroparesis
mesh term: Diabetes Mellitus
mesh term: Metoclopramide
mesh term: Maleic acid
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
provided document: 
provided document: 
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 