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Baxdrostat Bioavailability and Bioequivalence Study

Hypertension Clinical Trial

Official title:
Randomized, Open Label, Crossover Study to Evaluate the Relative Bioavailability of a New Tablet Formulation of CIN-107 as Compared to Oral Solution and to Assess the Effect of Food on the CIN-107 Tablet Formulation in Healthy Subjects

Clinical Trial Summary

The goal of this study was to compare the characteristics of a new tablet formulation versus an oral solution of CIN-107 (baxdrostat) in terms of CIN-107 levels over time in the blood and to compare the effect of food on these parameters in healthy volunteer participants who received the CIN-107 tablet under fed versus fasted conditions.

Clinical Trial Description

The goals of this study were to: 1. To assess the safety and tolerability of single doses of CIN-107 tablet and oral solution in healthy participants. 2. Compare CIN-107 levels over time in the blood in participants after dosing between a tablet formulation of CIN-107 as compared to the oral solution. 3. Compare the CIN-107 levels over time in the blood in participants following dosing with a CIN-107 tablet after a meal versus in the fasted state. Participants took either the oral solution or a tablet of CIN-107 and had their safety and blood levels of CIN-107 measured over several days following administration of CIN-107 tablet either in the fasted state or after a meal. The CIN-107 blood levels over time were compared between the groups given either the oral solution or the tablet and between the group given the CIN-107 tablet with a meal versus in the fasted state. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05963009
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 1
Start date March 11, 2020
Completion date April 29, 2020
View Details
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