Study identifier:CIN-107-126
ClinicalTrials.gov identifier:NCT05966324
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1 Single and Multiple Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Baxdrostat in Healthy Japanese and Caucasian Subjects
hypertension
Phase 1
Yes
baxdrostat
All
41
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2023 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
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 | Drug: baxdrostat Baxdrostat is an aldosterone synthase inhibitor Other Name: CIN-107 |
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 | Drug: baxdrostat Baxdrostat is an aldosterone synthase inhibitor Other Name: CIN-107 |
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 | Drug: baxdrostat Baxdrostat is an aldosterone synthase inhibitor Other Name: CIN-107 |
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 | Drug: baxdrostat Baxdrostat is an aldosterone synthase inhibitor Other Name: CIN-107 |