Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol Administered Under Fed Conditions in Healthy Chinese Volunteers
Condition: Healthy Volunteers
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-site, randomized, double-blind, double dummy, placebo-controlled single and
      multiple doses study of Aramchol in healthy Chinese volunteers. The subject population that
      was enrolled for Aramchol 004 was not specifically designed to understand the PK profile of
      Aramchol in subjects of Chinese descent. Therefore, this study (Aramchol 015) has been
      undertaken to ascertain the PK profile of Aramchol following single and multiple doses in a
      Chinese population under fed conditions utilizing the light breakfast from Aramchol 004.

      This study will consist of two parts and the subjects will be assigned to two parts.

      In each part of the study, subjects will be enrolled in the study within 28 days of
      screening.
    

Detailed description: 
      In each part of the study, subjects will be enrolled in the study within 28 days of
      screening. The study will consist of two parts, and the subjects will be assigned as follows:
      Part A- single escalating doses This part of the study is a single-site, randomized,
      double-blind, double dummy, placebo-controlled single-dose study of Aramchol in healthy
      Chinese volunteers. The purpose of Part A is to evaluate the PK, safety and tolerability of
      Aramchol tablets at single doses of either 400 mg or 600 mg.

      Thirty-two (32) subjects will participate in this part of the study and will be randomized to
      receive a single-dose of 400 mg Aramchol, 600 mg Aramchol, or Placebo. Drug administration
      will be preceded by a light breakfast consumed within 1 hour prior to dosing. All drugs will
      be administered by the study staff. In order to maintain blinding, all subjects will receive
      two tablets on each dosing, according to the following administrations:

        -  Cohort A: 1 x 200 mg Placebo tablet + 1 x 400 mg Aramchol tablet (12 subjects)

        -  Cohort B: 1 x 200 mg Aramchol tablet + 1 x 400 mg Aramchol tablet (12 subjects)

        -  Cohort C: 1 x 200mg Placebo tablet + 1 x 400 mg Placebo tablet (8 subjects) Subjects
           will be admitted in-house in the evening before the first study drug administration (Day
           0) and will remain in-house for 36 hours after dosing. Blood samples for Aramchol
           concentrations will be drawn for 36 hours at designated time points as described below.
           Additional ambulatory samples will be collected at 48, 72, 96, and 144 hours postdose.
           Subjects will be continuously monitored for safety. An End-of Study/Safety Follow-up
           visit will take place on the last PK sampling day, ie, 144 hours after the last dose
           administration.

      If the PK profile from Part A is similar to the existing PK data in non- Chinese subjects,
      then the study may be stopped. If the PK profile is different, then Part B of the study may
      be performed.

      Part B- multiple escalating doses Part B of the study is a single-site, randomized,
      double-blind, doubledummy, placebo-controlled multiple-dose study of Aramchol in healthy
      Chinese volunteers. The purpose of this part is to evaluate the PK, safety and tolerability
      of Aramchol tablets at multiple administrations of two different doses. Thirty-two (32)
      subjects will participate in this part of the study and will be equally randomized to receive
      400 mg Aramchol, 600 mg Aramchol, or Placebo for 10 consecutive days. Screening for Part B
      may begin during PK analysis of Part A. Part A subjects can enroll into Part B with sponsor
      approval. Drug administration will be preceded by a light breakfast consumed within 1 hour
      prior to dosing. All drugs will be administered by the study staff. In order to maintain
      blinding, all subjects will receive two tablets on each dosing, according to the following
      administrations:

        -  Cohort D: 1 x 200 mg Placebo tablet + 1 x 400 mg Aramchol tablet (12 subjects)

        -  Cohort E: 1 x 200 mg Aramchol tablet + 1 x 400 mg Aramchol tablet (12 subjects)

        -  Cohort F: 1 x 200 mg Placebo tablet + 1 x 400 mg Placebo tablet (8 subjects) Subjects
           will be admitted in-house in the evening before the first study drug administration (Day
           0) and will remain in-house for 24 and 36 hours after first (Day 1) and last (Day 10)
           doses, respectively; subjects will return for all other visits. PK blood samples will be
           drawn on Day 1 over 24 hours at designated time points as described below. Additionally,
           pre-dose (trough) samples will be drawn before dosing on Days 2, 3, 4, 5, 7, 8, and 9.
           On Day 10, blood samples will be collected over 36 hours at designated time points as
           described below and during additional visits at 48, 96, 120, 144, 168 and 192 hours
           post-dose. Subjects will be continuously monitored for safety. An End-of Study/Safety
           Follow-up visit will take place on the last PK sampling day, ie, 192 hours after the
           last dose administration.
    

Intervention name(s): Aramchol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part A: Aramchol oral tablets at 400 mg or 600 mg single dose Part B: Aramchol oral tablets at 400 mg or 600 mg multiple dose for 10 consecutive days.; Part A: Placebo oral tablets single dose Part B: Placebo oral tablets multiple dose for 10 consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)