A Study to Assess the Effect AZD4831 in Japanese and Chinese Healthy Volunteers
Condition: Heart Failure With Preserved Ejection Fraction (HFpEF)
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is randomized, single-blind, placebo-controlled Phase 1 study aimed to assess the
      safety and efficacy, pharmacokinetics and pharmacodynamics of multiple doses of oral AZD4831
      in healthy Japanese and Chinese volunteers
    

Detailed description: 
      This is a Phase I, randomized, single-blind, placebo-controlled, multiple-ascending dose
      (MAD), sequential-group study in healthy Japanese (Part 1, Cohorts 1, 2, and 3) and Chinese
      (Part 2, Cohort 4) male subjects, conducted at a single study center. Four cohorts are
      planned, but one additional cohort may be enrolled based on a Safety Review Committee (SRC)
      decision.

      The 4 multiple dose levels are planned as follows:

        -  Cohort 1: Dose 1

        -  Cohort 2: Dose 2

        -  Cohort 3: Dose 3

        -  Cohort 4: Dose 2

      A randomization ratio of 3:1 (AZD4831 versus placebo) will be used.

      For each cohort the study will comprise:

        -  Screening Period of a maximum of 28 days.

        -  A Treatment Period during which subjects are resident in the study center from the day
           before first dosing with the Investigational Medicinal Product (Day -1) until at least
           48 hours after last dosing on Day 10; subjects will be discharged on Day 12.

        -  Three Follow-up Visits on Day 14, Day 16 (±1 day), and Day 20 (±1 day).

        -  A Final Follow-up Visit on Day 24 (±2 days).

      Each subject will be involved in the study for 8 to 9 weeks.
    

Intervention name(s): AZD4831; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be fasted for at least 10 hours before receiving the AZD4831 in the form of an oral suspension.; Subjects will be fasted for at least 10 hours before receiving the placebo in the form of an oral suspension.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study will be a randomized, single-blind, placebo-controlled, MAD sequential-group study in healthy Japanese (Part 1, Cohorts 1, 2, and 3) and Chinese (Part 2, Cohort 4) male subjects, conducted at a single study center. Up to 40 healthy male subjects aged 18 to 50 years (inclusive) are planned to be investigated in 4 cohorts, but up to 5 cohorts may be included if the SRC considers it necessary to repeat a dose level or if additional dose levels are required.
Up to 8 subjects will participate in each cohort. Within each cohort 6 subjects will be randomly assigned to receive AZD4831 and 2 subjects to receive placebo. AZD4831 or placebo will be administered once daily for a period of 10 days. It is anticipated this will be sufficient to achieve and maintain steady state pharmacokinetic (PK) profiles for several days, permitting evaluation of the safety and tolerability of multiple dose. The subjects will stay at the study center during the whole dosing period and until 48 hours.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Randomized; Single-blind; Placebo-controlled; Multiple-ascending dose; AZD4831 oral suspension