Baxdrostat Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Japanese Population

Part of paid clinical trials in Anaheim, California.

Sponsor
AstraZeneca
Study ID
NCT05966324
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • baxdrostat — DRUG
    Baxdrostat is an aldosterone synthase inhibitor

Study Details

The goal of this study is to compare the characteristics of baxdrostat (CIN-107) in terms of baxdrostat levels over time in the blood in healthy Japanese and Caucasian volunteer participants.

Key Dates

Start date
Jul 5, 2022
Status verified
Aug 2023
Primary completion
Sep 20, 2022
Completion
Sep 20, 2022

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Oral tablet dose of baxdrostat 1 mg or placebo, administered as a single dose (Day 1) and multiple doses (once daily \[QD\] for 5 days, Days 6 - 10) to Japanese subjects
  • Experimental: Cohort 2
    Oral tablet dose of baxdrostat 3 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Japanese subjects
  • Experimental: Cohort 3
    Oral tablet dose of baxdrostat 3 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Caucasian subjects
  • Experimental: Cohort 4
    Oral tablet dose of baxdrostat 10 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Japanese subjects

Primary Outcome Measure

Incidence of treatment emergent adverse events following single and multiple doses of baxdrostat in healthy Japanese and Caucasian participants versus placebo recipients. [ Time Frame: 0 to 19 days after dosing ]

Locations (1)

FacilityCityStateZIPSite coordinators
Anaheim Clinical TrialsAnaheimCalifornia92801-

Find similar trials in Anaheim, CA

By condition
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By specialty
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By research site
Anaheim Clinical Trials· Anaheim, CA

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