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Baxdrostat Bioavailability and Bioequivalence Study

NCT05963009 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-08-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

baxdrostat (formerly CIN-107) oral solution

5 mg single dose of baxdrostat given as either a solution or tablet in either the fed or fasted state, depending on the arm of the study

Sponsors & Collaborators

Principal Investigators

  • L Vrishabhendra, MD · Medpace, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2020-04-29
Completion
2020-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05963009 on ClinicalTrials.gov