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Phase 1 Study to Determine the Metabolism and Clearance of Baxdrostat

NCT05961384 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-08-15

No results posted yet for this study

Summary

This was a Phase 1, open-label, single dose study in healthy male subjects. The goals of this clinical trial were to determine how baxdrostat might be absorbed and metabolized using radioactive \[14C\] labeled baxdrostat. Subjects were administered a single oral dose of 10 mg containing approximately 100 μCi of \[14C\] baxdrostat. Subjects were to be confined to the study site for 9 to 15 days for blood, urine, and feces collections.

Conditions

Interventions

DRUG

baxdrostat

a blood pressure lowering drug, oral dose

Sponsors & Collaborators

Principal Investigators

  • Nicholas Siebers, MD Siebers, MD · Labcorp Clinical Research Unit, Madison, Wisconsin, USA 53704

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2022-01-15
Completion
2022-01-15
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 NCT05961384 on ClinicalTrials.gov