<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/NCT04467684</url>
  </required_header>
  <id_info>
    <org_study_id>CB0406-12047</org_study_id>
    <nct_id>NCT04467684</nct_id>
  </id_info>
  <brief_title>Study Investigating the Safety, Tolerability, and PK, PD, of CB-0406</brief_title>
  <official_title>A Phase 1, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study Investigating the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of CB-0406 Tablets in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CymaBay Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CymaBay Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed as a single center, randomized, double-blind, placebo-controlled study&#xD;
      to assess the PK, safety, tolerability and PD of CB-0406 in healthy participants. The study&#xD;
      will be conducted as a 2-part study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed as a 2-part study:&#xD;
&#xD;
      Part 1 is designed as single ascending dose (SAD) escalation study investigating 5 dose&#xD;
      levels. Each cohort will consist of participants (N=8) to be randomly assigned to receive a&#xD;
      blinded oral dose of CB-0406 (n=6) or placebo (n=2). Dose levels of CB-0406 in the sequential&#xD;
      cohorts will be 100 mg, 200 mg, 400 mg, 800 mg or 1000 mg to be administered once on each&#xD;
      cohorts study Day 1.&#xD;
&#xD;
      Part 2 is designed as multiple ascending dose (MAD) escalation study investigating up to 5&#xD;
      dose levels as determined by the SAD cohort. Doses will be determined following completion&#xD;
      and review of the safety and PK findings for Cohorts 1 to Cohort 5 in Part 1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">June 6, 2021</completion_date>
  <primary_completion_date type="Actual">May 30, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The assignment to either CB-0406 or placebo will be blinded to the participants, investigators and staff at the study site. The pharmacy team will be unblinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic Parameters</measure>
    <time_frame>Part 1: Day 1 to Day 15; Part 2: Day 14 to Day 28</time_frame>
    <description>Concentration of CB-0406 in plasma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>Part 1: Day 1 to Day 22; Part 2: Day 1 to Day 35</time_frame>
    <description>Incidence of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic Activity</measure>
    <time_frame>Part 1: Day 1 to Day 15; Part 2: Day 14 to Day 28</time_frame>
    <description>Evaluation of relative changes from baseline in plasma IL-1β and serum urate over time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of abnormal laboratory tests results</measure>
    <time_frame>Part 1: Screening, Day -1, Day 2, Day 4, Day 9, Day 15, EOS/ET Part 2: Screening, Day -1, Day 2 to 13, Day 14, Day 16, Day 20, Day 28, EOS/ET</time_frame>
    <description>Evaluation of clinically significant changes from baseline in laboratory evaluation (hematology, chemistry, coagulation, urinalysis)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Abnormal Vital Signs</measure>
    <time_frame>Part 1: Every visit; Part 2 Every visit</time_frame>
    <description>Evaluation of clinically significant changes in vital signs will include body temperature (tympanic), respiratory rate, heart rate and systolic and diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Abnormal ECGs</measure>
    <time_frame>Part 1: Screening, Day 1, Day 2, Day 3, Day 4, Day 9, Day 15, EOS/ET; Part 2 Screening, Day 1, Day 2 to 13, Day 14, Day 16, Day 20, Day 28, Day 35</time_frame>
    <description>The following parameters will be assessed using a 12-lead ECG: heart rate, PR, QRS, QT, QTcF (Fridericia's formula).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Abnormal Physical Exams</measure>
    <time_frame>Part 1: Day -1 and at the EOS/ET visit; Part 2 Screening, Day 1, Day 2 to 13, Day 4, Day 16, Day 20, Day 28, EOS/ET</time_frame>
    <description>Assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen)</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 1: 100 mg CB-0406 (n=6)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 2: 200 mg CB-0406 (n=6). Dose initiated following review of all safety data from Cohort 1 by a Safety Review Committee</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 3: 400 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 2 by a Safety Review Committee.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>800 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 4: 800 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 3 by a Safety Review Committee.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1000 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 5: 1000 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 4 by a Safety Review Committee</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matched placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two subjects in each Cohort (1, 2, 3, 4, 5) are randomized to matched placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CB-0406 100 mg</intervention_name>
    <description>Single oral dose</description>
    <arm_group_label>Cohort 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CB-0406 200 mg</intervention_name>
    <description>Single oral dose</description>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CB-0406 400 mg</intervention_name>
    <description>Single oral dose</description>
    <arm_group_label>Cohort 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CB-0406 800 mg</intervention_name>
    <description>Single oral dose</description>
    <arm_group_label>800 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CB-0406 1,000 mg</intervention_name>
    <description>Single oral dose</description>
    <arm_group_label>1000 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matched placebo</intervention_name>
    <description>Color and size matched placebo</description>
    <arm_group_label>Matched placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be eligible for study entry participants must satisfy all of the following criteria:&#xD;
&#xD;
          1. Provide written informed consent before any study specific evaluation is performed;&#xD;
&#xD;
          2. Healthy adult male and female volunteers between the ages of 18 and 65 years,&#xD;
             inclusive, at screening;&#xD;
&#xD;
          3. A female participant is eligible to participate if she is not pregnant, not&#xD;
             breastfeeding, and at least 1 of the following conditions applies:&#xD;
&#xD;
               -  Not of childbearing potential, defined as surgically sterile (documented&#xD;
                  hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy -&#xD;
                  verbal confirmation through medical history review acceptable) or postmenopausal&#xD;
                  (no menses for 12 months without an alternative medical cause. A high follicle&#xD;
                  stimulating hormone (FSH) level in the postmenopausal range may be used to&#xD;
                  confirm a postmenopausal state in women not using hormonal contraception or&#xD;
                  hormonal replacement therapy; however, in the absence of 12 months of amenorrhea,&#xD;
                  a single FSH measurement is insufficient);&#xD;
&#xD;
               -  Of childbearing potential and agrees to use a highly effective method of&#xD;
                  contraception consistently during the treatment period and for at least 30 days&#xD;
                  after the dose of study treatment;&#xD;
&#xD;
          4. A male patient with a female partner of childbearing potential is eligible to&#xD;
             participate if he and his female partner agrees to use acceptable contraception during&#xD;
             the treatment period and for at least 30 days after the last dose of study treatment&#xD;
             and refrains from donating sperm during this period.&#xD;
&#xD;
          5. Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening;&#xD;
&#xD;
          6. Hematology, clinical chemistry, coagulation and urinalysis test results within normal&#xD;
             ranges or has no clinically relevant deviations, as determined by the investigator in&#xD;
             consultation with sponsor, at screening and Day -1. Tests with out of range values at&#xD;
             screening or Day -1 may be repeated once per assessment point;&#xD;
&#xD;
          7. No clinically significant abnormalities noted in medical history; or discovered by&#xD;
             physical examination, ECG assessment, or measurement of vital signs at screening and&#xD;
             Day -1;&#xD;
&#xD;
          8. Able and willing to abstain from alcohol, caffeine or caffeine-containing products,&#xD;
             grapefruit or grapefruit juice, St John's wort, and herbal supplements for from 24&#xD;
             hours before Day -1 until the end of the confinement period and for 24 hours prior to&#xD;
             additional visits to the study site.&#xD;
&#xD;
          9. Agree to not engage in heavy exercise (e.g., marathon runners, weight-lifting) within&#xD;
             1 week prior to dosing until the final study visit.&#xD;
&#xD;
         10. Able and willing to comply with the protocol and study procedures;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants will be excluded from the study if one or more of the following criterion are&#xD;
        applicable:&#xD;
&#xD;
          1. Has an active or recurring clinically significant disorder of the skin, head, ears,&#xD;
             eyes, nose, or throat; an active or recurring clinically significant disorder of the&#xD;
             respiratory, cardiovascular, gastrointestinal, endocrine/metabolic, genitourinary,&#xD;
             neurologic, hematologic, musculoskeletal, immunologic, or psychological/psychiatric&#xD;
             system; or a disease requiring medical treatment;&#xD;
&#xD;
          2. Previous history of any surgical or medical condition that might significantly alter&#xD;
             the absorption, distribution, metabolism, or excretion of CB-0406, such as stomach or&#xD;
             intestinal surgery or resection (e.g., gastrectomy or any type of gastric by-pass&#xD;
             surgery or gastric banding procedure);&#xD;
&#xD;
          3. Planning any elective medical treatment or surgery during the trial period or within&#xD;
             30 days of Day -1;&#xD;
&#xD;
          4. Any evidence or treatment of malignancy (other than localized basal cell cancer,&#xD;
             squamous cell skin cancer, or cancer in situ that has been resected) within the&#xD;
             previous 5 years;&#xD;
&#xD;
          5. Known history of allergic reactions to or have previously received arhalofenate,&#xD;
             MBX-102, JNJ39659100, Metaglidasen, and/or K 118;&#xD;
&#xD;
          6. Previous history or evidence at screening of sick sinus syndrome or second- or&#xD;
             third-degree atrioventricular block or any cardiac arrhythmia other than a benign&#xD;
             sinus arrhythmia. Participant has not had a myocardial infarction within the last 6&#xD;
             months;&#xD;
&#xD;
          7. Clinically significant renal disease, nephrectomy, renal transplant or estimated&#xD;
             glomerular filtration rate of &lt;90 mL/min/1.73 m2 at screening based on Chronic Kidney&#xD;
             Disease Epidemiology Collaboration creatinine equation (2009).&#xD;
&#xD;
          8. Blood pressure after resting for at least 5 minutes that is higher than 150 mm Hg&#xD;
             systolic or 95 mm Hg diastolic, or lower than 90 mm Hg systolic or 50 mm Hg diastolic&#xD;
             at screening or Day -1. A single repeat measurement at screening or Day -1 is allowed&#xD;
             based on the investigator's judgment;&#xD;
&#xD;
          9. Pulse rate obtained from vital signs after resting for 5 minutes that is outside the&#xD;
             range of 45 to 90 beats per minute at screening or Day -1. A single repeat measurement&#xD;
             is allowed at screening and Day -1 for eligibility based on the investigator's&#xD;
             judgment;&#xD;
&#xD;
         10. History of drug or alcohol abuse within the last 2 years;&#xD;
&#xD;
         11. Positive screen for drugs of abuse (amphetamines, methamphetamines, methadone,&#xD;
             barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine,&#xD;
             phencyclidine, tetrahydrocannabinol), tricyclic antidepressants, cotinine or alcohol&#xD;
             at screening or Day -1;&#xD;
&#xD;
         12. Smoke more than 2 cigarettes per week and have a positive cotinine test at screening&#xD;
             or Day -1. Participants must agree to refrain from smoking from 24 hours prior to Day&#xD;
             -1 until completion of the end of study (EOS) visit.&#xD;
&#xD;
         13. Used or are using prescription or over-the-counter medications, dietary/nutritional&#xD;
             supplements (except for multivitamins at the recommended dose and paracetamol, up to&#xD;
             2g in any one day) within 14 days prior to Day 1 and for the duration of the trial.&#xD;
&#xD;
         14. Received an investigational drug within 30 days or 5 half -lives (whichever is longer)&#xD;
             prior to Day 1.&#xD;
&#xD;
         15. Donated more than 450 mL of blood within 30 days prior to Day 1;&#xD;
&#xD;
         16. Evidence of clinically significant hepatic impairment including alanine&#xD;
             aminotransferase or aspartate aminotransferase &gt;1.5 times the upper limit of normal,&#xD;
             with the exception of elevated bilirubin due to Gilbert's syndrome based on bilirubin&#xD;
             fractionation at screening;&#xD;
&#xD;
         17. Positive test result at screening for human immunodeficiency virus (Types 1 or 2)&#xD;
             antibody, hepatitis B surface antigen, or hepatitis C virus antibody;&#xD;
&#xD;
         18. Clinically significant acute illness within 4 weeks or other illness deemed to be&#xD;
             significant by investigator with agreement of sponsor within 5 days before Day 1;&#xD;
&#xD;
         19. Participant or a family member of the participant is a member of the professional or&#xD;
             ancillary personnel working at the investigative site involved in the study;&#xD;
&#xD;
         20. Participant, in the opinion of the investigator, should not participate in the study;&#xD;
&#xD;
         21. Participant has received blood products within 2 months prior to Day -1.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elaine Watkins, DO, MSPH</last_name>
    <role>Study Director</role>
    <affiliation>CymaBay Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nucleus Network</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3181</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <link>
    <url>http://www.cymabay.com/</url>
    <description>CymaBay Therapeutics</description>
  </link>
  <reference>
    <citation>Aronow WS, Harding PR, Khursheed M, Vangrow JS, Papageorge's NP, Mays J. Effect of halofenate on serum lipids. Clin Pharmacol Ther. 1973 May-Jun;14(3):358-65. doi: 10.1002/cpt1973143358. No abstract available.</citation>
    <PMID>4572798</PMID>
  </reference>
  <reference>
    <citation>Dujovne CA, Azarnoff DL, Pentikainen P, Manion C, Hurwitz A, Hassanein K. A two-year crossover therapeutic trial with halofenate and clofibrate. Am J Med Sci. 1976 Nov-Dec;272(3):277-84. doi: 10.1097/00000441-197611000-00005.</citation>
    <PMID>797258</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>June 10, 2021</last_update_submitted>
  <last_update_submitted_qc>June 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>single ascending dose (SAD)</keyword>
  <keyword>multiple ascending dose (MAD)</keyword>
  <keyword>CymaBay</keyword>
  <keyword>CB-0406</keyword>
  <keyword>arhalofenate</keyword>
  <keyword>peroxisome proliferator-activated receptor gamma</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 31, 2022</submitted>
    <returned>March 6, 2023</returned>
  </pending_results>
  <!-- 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/NCT04467684
org study id: CB0406-12047
nct id: NCT04467684
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study is designed as a single center, randomized, double-blind, placebo-controlled study
      to assess the PK, safety, tolerability and PD of CB-0406 in healthy participants. The study
      will be conducted as a 2-part study.
The study is designed as a 2-part study:

      Part 1 is designed as single ascending dose (SAD) escalation study investigating 5 dose
      levels. Each cohort will consist of participants (N=8) to be randomly assigned to receive a
      blinded oral dose of CB-0406 (n=6) or placebo (n=2). Dose levels of CB-0406 in the sequential
      cohorts will be 100 mg, 200 mg, 400 mg, 800 mg or 1000 mg to be administered once on each
      cohorts study Day 1.

      Part 2 is designed as multiple ascending dose (MAD) escalation study investigating up to 5
      dose levels as determined by the SAD cohort. Doses will be determined following completion
      and review of the safety and PK findings for Cohorts 1 to Cohort 5 in Part 1.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The assignment to either CB-0406 or placebo will be blinded to the participants, investigators and staff at the study site. The pharmacy team will be unblinded.
measure: Pharmacokinetic Parameters
time frame: Part 1: Day 1 to Day 15; Part 2: Day 14 to Day 28
description: Concentration of CB-0406 in plasma.
measure: Incidence of Treatment-Emergent Adverse Events
time frame: Part 1: Day 1 to Day 22; Part 2: Day 1 to Day 35
description: Incidence of adverse events
measure: Pharmacodynamic Activity
time frame: Part 1: Day 1 to Day 15; Part 2: Day 14 to Day 28
description: Evaluation of relative changes from baseline in plasma IL-1β and serum urate over time
measure: Incidence of abnormal laboratory tests results
time frame: Part 1: Screening, Day -1, Day 2, Day 4, Day 9, Day 15, EOS/ET Part 2: Screening, Day -1, Day 2 to 13, Day 14, Day 16, Day 20, Day 28, EOS/ET
description: Evaluation of clinically significant changes from baseline in laboratory evaluation (hematology, chemistry, coagulation, urinalysis)
measure: Incidence of Abnormal Vital Signs
time frame: Part 1: Every visit; Part 2 Every visit
description: Evaluation of clinically significant changes in vital signs will include body temperature (tympanic), respiratory rate, heart rate and systolic and diastolic blood pressure
measure: Incidence of Abnormal ECGs
time frame: Part 1: Screening, Day 1, Day 2, Day 3, Day 4, Day 9, Day 15, EOS/ET; Part 2 Screening, Day 1, Day 2 to 13, Day 14, Day 16, Day 20, Day 28, Day 35
description: The following parameters will be assessed using a 12-lead ECG: heart rate, PR, QRS, QT, QTcF (Fridericia's formula).
measure: Incidence of Abnormal Physical Exams
time frame: Part 1: Day -1 and at the EOS/ET visit; Part 2 Screening, Day 1, Day 2 to 13, Day 4, Day 16, Day 20, Day 28, EOS/ET
description: Assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen)
arm group label: Cohort 1
arm group type: Experimental
description: Cohort 1: 100 mg CB-0406 (n=6)
arm group label: Cohort 2
arm group type: Experimental
description: Cohort 2: 200 mg CB-0406 (n=6). Dose initiated following review of all safety data from Cohort 1 by a Safety Review Committee
arm group label: Cohort 3
arm group type: Experimental
description: Cohort 3: 400 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 2 by a Safety Review Committee.
arm group label: 800 mg
arm group type: Experimental
description: Cohort 4: 800 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 3 by a Safety Review Committee.
arm group label: 1000 mg
arm group type: Experimental
description: Cohort 5: 1000 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 4 by a Safety Review Committee
arm group label: Matched placebo
arm group type: Placebo Comparator
description: Two subjects in each Cohort (1, 2, 3, 4, 5) are randomized to matched placebo
intervention type: Drug
intervention name: CB-0406 100 mg
description: Single oral dose
arm group label: Cohort 1
intervention type: Drug
intervention name: CB-0406 200 mg
description: Single oral dose
arm group label: Cohort 2
intervention type: Drug
intervention name: CB-0406 400 mg
description: Single oral dose
arm group label: Cohort 3
intervention type: Drug
intervention name: CB-0406 800 mg
description: Single oral dose
arm group label: 800 mg
intervention type: Drug
intervention name: CB-0406 1,000 mg
description: Single oral dose
arm group label: 1000 mg
intervention type: Drug
intervention name: Matched placebo
description: Color and size matched placebo
arm group label: Matched placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elaine Watkins, DO, MSPH
role: Study Director
affiliation: CymaBay Therapeutics, Inc.
facility: 
country: Australia
url: http://www.cymabay.com/
description: CymaBay Therapeutics
citation: Aronow WS, Harding PR, Khursheed M, Vangrow JS, Papageorge's NP, Mays J. Effect of halofenate on serum lipids. Clin Pharmacol Ther. 1973 May-Jun;14(3):358-65. doi: 10.1002/cpt1973143358. No abstract available.
PMID: 4572798
citation: Dujovne CA, Azarnoff DL, Pentikainen P, Manion C, Hurwitz A, Hassanein K. A two-year crossover therapeutic trial with halofenate and clofibrate. Am J Med Sci. 1976 Nov-Dec;272(3):277-84. doi: 10.1097/00000441-197611000-00005.
PMID: 797258
responsible party type: Sponsor
sharing ipd: No
submitted: May 31, 2022
returned: March 6, 2023