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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
41
Baxdrostat is an aldosterone synthase inhibitor
Anaheim Clinical Trials
Anaheim, California, United States
Incidence of treatment emergent adverse events following single and multiple doses of baxdrostat in healthy Japanese and Caucasian participants versus placebo recipients.
Safety and tolerability will be assessed by comparison of number of treatment emergent adverse events between groups.
Time frame: 0 to 19 days after dosing
Area under the curve (AUC) for baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
AUC \[0 to 24 hours, 0 to last quantifiable concentration, and 0 to infinity of baxdrostat\] will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Time frame: 0 to 15 days after dosing
Maximum Plasma Concentration [Cmax] of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
Cmax will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Time frame: 0 to 15 days after dosing
Plasma aldosterone levels following single and multiple oral doses of baxdrostat in healthy Japanese subjects.
Plasma aldosterone levels will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Time frame: 0 to 15 days after dosing
Time to Maximum Plasma Concentration [Tmax] of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
Tmax will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Time frame: 0 to 15 days after dosing
Terminal elimination half-life of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
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Terminal elimination half-life will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Time frame: 0 to 15 days after dosing