<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/NCT04435483</url>
  </required_header>
  <id_info>
    <org_study_id>D822FC00004</org_study_id>
    <nct_id>NCT04435483</nct_id>
  </id_info>
  <brief_title>A Study of Acalabrutinib Suspension to Evaluate Relative Bioavailability and Proton-pump Inhibitor Effect in Healthy Volunteers</brief_title>
  <official_title>Phase I, Open-label, Single-dose, Sequential, Randomized, Crossover Study of Acalabrutinib Suspension Delivered Via Nasogastric Tube in Healthy Subjects to Evaluate Relative Bioavailability and Proton-pump Inhibitor (Rabeprazole) Effect</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Acerta Pharma, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</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>
      This study is being conducted to support the clinical development of acalabrutinib in&#xD;
      patients who are unable to swallow capsule and require nasogastric (NG) tube placement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, single-center, randomized, 3-period, crossover study of acalabrutinib&#xD;
      suspension administered via NG tube in healthy subjects to evaluate the relative&#xD;
      bioavailability and proton-pump inhibitor (rabeprazole) effect.&#xD;
&#xD;
      The study is divided in 3 periods.&#xD;
&#xD;
      Period 1 of the study is designed to investigate the effect of proton-pump inhibitor on the&#xD;
      pharmacokinetics (PK) of acalabrutinib suspension. Period 2 and 3 of the study are designed&#xD;
      to investigate the bioavailability of acalabrutinib suspension relative to an oral capsule&#xD;
      formulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2020</start_date>
  <completion_date type="Actual">June 26, 2020</completion_date>
  <primary_completion_date type="Actual">June 26, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acalabrutinib and ACP-5862 plasma PK parameter: Area under plasma concentration-time curve from time zero to infinity (AUCinf)</measure>
    <time_frame>Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours (h) post-dose</time_frame>
    <description>To compare the AUCinf of the acala NG suspension with and without rabeprazole. To compare the AUC of the acala NG suspension with the oral capsule.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acalabrutinib and ACP-5862 plasma PK parameter: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)</measure>
    <time_frame>Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose</time_frame>
    <description>To compare the AUClast of the acala NG suspension with and without rabeprazole. To compare the AUClast of the acala NG suspension with the oral capsule.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acalabrutinib and ACP-5862 plasma PK parameter: Maximum observed plasma concentration (Cmax)</measure>
    <time_frame>Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose</time_frame>
    <description>To compare the Cmax of the acala NG suspension with and without rabeprazole. To compare the Cmax of the acala NG suspension with the oral capsule.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acalabrutinib and ACP-5862 plasma PK parameter: Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)</measure>
    <time_frame>Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose</time_frame>
    <description>To compare the AUC0-24 of the acala NG suspension with and without rabeprazole. To compare the AUC0-24 of the acala NG suspension with the oral capsule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acalabrutinib and ACP-5862 plasma PK parameter: Time to reach maximum observed plasma concentration (tmax)</measure>
    <time_frame>Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose</time_frame>
    <description>To compare the tmax of the acala NG suspension with and without rabeprazole. To compare the tmax of the acala NG suspension with the oral capsule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acalabrutinib and ACP-5862 plasma PK parameter: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2)</measure>
    <time_frame>Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose</time_frame>
    <description>To compare the t1/2 of the acala NG suspension with and without rabeprazole. To compare the t1/2 of the acala NG suspension with the oral capsule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acalabrutinib and ACP-5862 plasma PK parameter: Mean residence time of the drug in the systemic circulation from zero to infinity (MRT)</measure>
    <time_frame>Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose</time_frame>
    <description>To compare the MRT of the acala NG suspension with and without rabeprazole. To compare the MRT of the acala NG suspension with the oral capsule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acalabrutinib and ACP-5862 plasma PK parameter: Terminal elimination rate constant (λz)</measure>
    <time_frame>Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose</time_frame>
    <description>To compare the λz of the acala NG suspension with and without rabeprazole. To compare the λz of the acala NG suspension with the oral capsule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acalabrutinib and ACP-5862 plasma PK parameter: Apparent total body clearance of drug from plasma after extravascular administration (acalabrutinib only) (CL/F)</measure>
    <time_frame>Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose</time_frame>
    <description>To compare the CL/F of the acala NG suspension with and without rabeprazole. To compare the CL/F of the acala NG suspension with the oral capsule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acalabrutinib and ACP-5862 plasma PK parameter: Apparent volume of distribution during the terminal phase after extravascular administration (acalabrutinib only) (Vz/F)</measure>
    <time_frame>Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose</time_frame>
    <description>To compare the Vz/F of the acala NG suspension with and without rabeprazole. To compare the Vz/F of the acala NG suspension with the oral capsule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acalabrutinib and ACP-5862 plasma PK parameter: Metabolite to parent ratio based on AUCinf and/or AUClast (M:P[AUC])</measure>
    <time_frame>Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose</time_frame>
    <description>To compare the M:P[AUC] of the acala NG suspension with and without rabeprazole. To compare the M:P[AUC] of the acala NG suspension with the oral capsule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acalabrutinib and ACP-5862 plasma PK parameter: Metabolite to parent ratio based on Cmax (M:P[Cmax])</measure>
    <time_frame>Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose</time_frame>
    <description>To compare the M:P[Cmax] of the acala NG suspension with and without rabeprazole. To compare the M:P[Cmax] of the acala NG suspension with the oral capsule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with abnormal vital signs</measure>
    <time_frame>Screening, Day -1, and Day 2</time_frame>
    <description>To assess the safety and tolerability of single doses of acalabrutinib suspension in healthy participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with abnormal laboratory assessments</measure>
    <time_frame>Screening, Day -1, Days 1-2, and follow-up visit (7-10 days after last dose)</time_frame>
    <description>To assess the safety and tolerability of single doses of acalabrutinib suspension in healthy participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with serious and non-serious adverse events</measure>
    <time_frame>Screening (Day -28), Days -3, -2, -1, Days 1-3, and follow-up visit (7-10 days after last dose)</time_frame>
    <description>To assess the safety and tolerability of single doses of acalabrutinib suspension in healthy participants.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Pharmacokinetics</condition>
  <condition>Bioavailability</condition>
  <arm_group>
    <arm_group_label>Treatment Sequence 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment A (100 mg acalabrutinib suspension via NG administration plus 20 mg rabeprazole) in Period 1, Treatment B (100 mg acalabrutinib suspension via NG administration) in Period 2, and Treatment C (100 mg acalabrutinib capsule) in Period 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Sequence 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Treatment B (100 mg acalabrutinib suspension via NG administration) in Period 1, Treatment C (100 mg acalabrutinib capsule) in Period 2, and Treatment B (100 mg acalabrutinib suspension via NG administration) in Period 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acalabrutinib Treatment A</intervention_name>
    <description>Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions. A single dose of 20 mg rabeprazole will be administered with 240 mL water, 2 hours prior to administration of acalabrutinib suspension. Treatment with rabeprazole 20 mg twice daily (with meals) will be started 3 days prior to the receiving the first dose of acalabrutinib suspension.</description>
    <arm_group_label>Treatment Sequence 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acalabrutinib Treatment B</intervention_name>
    <description>Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions.</description>
    <arm_group_label>Treatment Sequence 1</arm_group_label>
    <arm_group_label>Treatment Sequence 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acalabrutinib Treatment C</intervention_name>
    <description>Participants will receive a single dose of 100-mg acalabrutinib capsule, under fasted conditions. The acalabrutinib capsule will be administered with 240 mL of water.</description>
    <arm_group_label>Treatment Sequence 1</arm_group_label>
    <arm_group_label>Treatment Sequence 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of signed and dated, written informed consent prior to any study-specific&#xD;
             procedures.&#xD;
&#xD;
          2. Healthy adult male and female subjects aged 18 to 55 years (inclusive) with suitable&#xD;
             veins for cannulation or repeated venipuncture.&#xD;
&#xD;
          3. Male subjects and their female partners/spouses must adhere to the contraception&#xD;
             methods.&#xD;
&#xD;
          4. Female subjects must have a negative pregnancy test at screening, must not be&#xD;
             lactating, and must be of non-childbearing potential.&#xD;
&#xD;
          5. Have a body mass index (BMI) between 18.5 and 30 kg/m2, inclusive, and weigh at least&#xD;
             50 kg and no more than 100 kg, inclusive, at screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History or presence of any clinically significant disease (including COVID-19) or&#xD;
             disorder which, in the opinion of the Investigator, may either put the subject at risk&#xD;
             because of participation in the study, or influence the results or the subject's&#xD;
             ability to participate in the study.&#xD;
&#xD;
          2. History or presence of gastrointestinal (GI), hepatic or renal disease, or any other&#xD;
             condition known to interfere with absorption, distribution, metabolism, or excretion&#xD;
             of drugs.&#xD;
&#xD;
          3. Any positive result on screening for serum hepatitis B surface antigen, hepatitis B&#xD;
             core antibody, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.&#xD;
&#xD;
          4. Plasma donation within 30 days of screening or any blood donation/loss more than 500&#xD;
             mL during the 90 days prior to screening.&#xD;
&#xD;
          5. Current smokers or those who have smoked or used nicotine products (including&#xD;
             e-cigarettes) within the 90 days prior to screening.&#xD;
&#xD;
          6. Positive screen for drugs of abuse or cotinine at screening.&#xD;
&#xD;
          7. Known or suspected history of alcohol or drug abuse, or excessive intake of alcohol as&#xD;
             judged by the Investigator.&#xD;
&#xD;
          8. Excessive intake of caffeine-containing drinks or food as judged by the Investigator.&#xD;
&#xD;
          9. Vulnerable subjects, eg, kept in detention, protected adults under guardianship,&#xD;
             trusteeship, or committed to an institution by governmental or juridical order.&#xD;
&#xD;
         10. History of a disorder which would make NG tube placement contraindicated, eg,&#xD;
             esophageal strictures, esophageal varices, or bleeding diathesis.&#xD;
&#xD;
         11. Evidence of ongoing systemic bacterial, fungal, or viral infection (including upper&#xD;
             respiratory tract infections). Subjects with localized cutaneous fungal infections are&#xD;
             eligible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Han, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>PAREXEL Early Phase Clinical Unit-Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Calquence</keyword>
  <keyword>Acalabrutinib</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acalabrutinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:&#xD;
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure</ipd_description>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:&#xD;
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:&#xD;
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04435483
org study id: D822FC00004
nct id: NCT04435483
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is being conducted to support the clinical development of acalabrutinib in
      patients who are unable to swallow capsule and require nasogastric (NG) tube placement.
This is an open-label, single-center, randomized, 3-period, crossover study of acalabrutinib
      suspension administered via NG tube in healthy subjects to evaluate the relative
      bioavailability and proton-pump inhibitor (rabeprazole) effect.

      The study is divided in 3 periods.

      Period 1 of the study is designed to investigate the effect of proton-pump inhibitor on the
      pharmacokinetics (PK) of acalabrutinib suspension. Period 2 and 3 of the study are designed
      to investigate the bioavailability of acalabrutinib suspension relative to an oral capsule
      formulation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acalabrutinib and ACP-5862 plasma PK parameter: Area under plasma concentration-time curve from time zero to infinity (AUCinf)
time frame: Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours (h) post-dose
description: To compare the AUCinf of the acala NG suspension with and without rabeprazole. To compare the AUC of the acala NG suspension with the oral capsule.
measure: Acalabrutinib and ACP-5862 plasma PK parameter: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)
time frame: Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose
description: To compare the AUClast of the acala NG suspension with and without rabeprazole. To compare the AUClast of the acala NG suspension with the oral capsule.
measure: Acalabrutinib and ACP-5862 plasma PK parameter: Maximum observed plasma concentration (Cmax)
time frame: Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose
description: To compare the Cmax of the acala NG suspension with and without rabeprazole. To compare the Cmax of the acala NG suspension with the oral capsule.
measure: Acalabrutinib and ACP-5862 plasma PK parameter: Area under the plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
time frame: Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose
description: To compare the AUC0-24 of the acala NG suspension with and without rabeprazole. To compare the AUC0-24 of the acala NG suspension with the oral capsule.
measure: Acalabrutinib and ACP-5862 plasma PK parameter: Time to reach maximum observed plasma concentration (tmax)
time frame: Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose
description: To compare the tmax of the acala NG suspension with and without rabeprazole. To compare the tmax of the acala NG suspension with the oral capsule.
measure: Acalabrutinib and ACP-5862 plasma PK parameter: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2)
time frame: Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose
description: To compare the t1/2 of the acala NG suspension with and without rabeprazole. To compare the t1/2 of the acala NG suspension with the oral capsule.
measure: Acalabrutinib and ACP-5862 plasma PK parameter: Mean residence time of the drug in the systemic circulation from zero to infinity (MRT)
time frame: Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose
description: To compare the MRT of the acala NG suspension with and without rabeprazole. To compare the MRT of the acala NG suspension with the oral capsule.
measure: Acalabrutinib and ACP-5862 plasma PK parameter: Terminal elimination rate constant (λz)
time frame: Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose
description: To compare the λz of the acala NG suspension with and without rabeprazole. To compare the λz of the acala NG suspension with the oral capsule.
measure: Acalabrutinib and ACP-5862 plasma PK parameter: Apparent total body clearance of drug from plasma after extravascular administration (acalabrutinib only) (CL/F)
time frame: Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose
description: To compare the CL/F of the acala NG suspension with and without rabeprazole. To compare the CL/F of the acala NG suspension with the oral capsule.
measure: Acalabrutinib and ACP-5862 plasma PK parameter: Apparent volume of distribution during the terminal phase after extravascular administration (acalabrutinib only) (Vz/F)
time frame: Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose
description: To compare the Vz/F of the acala NG suspension with and without rabeprazole. To compare the Vz/F of the acala NG suspension with the oral capsule.
measure: Acalabrutinib and ACP-5862 plasma PK parameter: Metabolite to parent ratio based on AUCinf and/or AUClast (M:P[AUC])
time frame: Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose
description: To compare the M:P[AUC] of the acala NG suspension with and without rabeprazole. To compare the M:P[AUC] of the acala NG suspension with the oral capsule.
measure: Acalabrutinib and ACP-5862 plasma PK parameter: Metabolite to parent ratio based on Cmax (M:P[Cmax])
time frame: Day 1 to 2: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 h post-dose
description: To compare the M:P[Cmax] of the acala NG suspension with and without rabeprazole. To compare the M:P[Cmax] of the acala NG suspension with the oral capsule.
measure: Number of subjects with abnormal vital signs
time frame: Screening, Day -1, and Day 2
description: To assess the safety and tolerability of single doses of acalabrutinib suspension in healthy participants.
measure: Number of subjects with abnormal laboratory assessments
time frame: Screening, Day -1, Days 1-2, and follow-up visit (7-10 days after last dose)
description: To assess the safety and tolerability of single doses of acalabrutinib suspension in healthy participants.
measure: Number of subjects with serious and non-serious adverse events
time frame: Screening (Day -28), Days -3, -2, -1, Days 1-3, and follow-up visit (7-10 days after last dose)
description: To assess the safety and tolerability of single doses of acalabrutinib suspension in healthy participants.
arm group label: Treatment Sequence 1
arm group type: Experimental
description: Participants will receive Treatment A (100 mg acalabrutinib suspension via NG administration plus 20 mg rabeprazole) in Period 1, Treatment B (100 mg acalabrutinib suspension via NG administration) in Period 2, and Treatment C (100 mg acalabrutinib capsule) in Period 3.
arm group label: Treatment Sequence 2
arm group type: Experimental
description: Participants will receive Treatment B (100 mg acalabrutinib suspension via NG administration) in Period 1, Treatment C (100 mg acalabrutinib capsule) in Period 2, and Treatment B (100 mg acalabrutinib suspension via NG administration) in Period 3.
intervention type: Drug
intervention name: Acalabrutinib Treatment A
description: Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions. A single dose of 20 mg rabeprazole will be administered with 240 mL water, 2 hours prior to administration of acalabrutinib suspension. Treatment with rabeprazole 20 mg twice daily (with meals) will be started 3 days prior to the receiving the first dose of acalabrutinib suspension.
arm group label: Treatment Sequence 1
intervention type: Drug
intervention name: Acalabrutinib Treatment B
description: Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions.
arm group label: Treatment Sequence 1
arm group label: Treatment Sequence 2
intervention type: Drug
intervention name: Acalabrutinib Treatment C
description: Participants will receive a single dose of 100-mg acalabrutinib capsule, under fasted conditions. The acalabrutinib capsule will be administered with 240 mL of water.
arm group label: Treatment Sequence 1
arm group label: Treatment Sequence 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Han, M.D.
role: Principal Investigator
affiliation: PAREXEL Early Phase Clinical Unit-Los Angeles
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acalabrutinib
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
ipd access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home