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

Hypertension Clinical Trial

Official title:
A Phase 1 Single and Multiple Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Baxdrostat in Healthy Japanese and Caucasian Subjects

Clinical Trial Summary

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.

Clinical Trial Description

Main Objectives were: - To assess the safety and tolerability of single and multiple oral doses of baxdrostat in healthy Japanese subjects. - To assess pharmacokinetics (PK) of baxdrostat and CIN-107-M after single and multiple oral doses of baxdrostat in healthy Japanese subjects. - To assess pharmacodynamic (PD) effects of single and multiple oral doses of baxdrostat in healthy Japanese subjects. - To compare the PK and PD of baxdrostat and CIN-107-M after single and multiple oral doses of baxdrostat between Japanese and Caucasian subjects. Participants will take baxdrostat and have their safety and blood levels of baxdrostat measured over several days following single and multiple dose administration of 3 different dose levels of baxdrostat. The baxdrostat blood levels over time and the levels of certain hormones that regulate blood pressure will be compared between the dose groups and between the healthy Japanese and Caucasian volunteer participants. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05966324
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 1
Start date July 5, 2022
Completion date September 20, 2022
View Details
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