Phase 1 Study to Determine the Metabolism and Clearance of Baxdrostat

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
AstraZeneca
Study ID
NCT05961384
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • baxdrostat — DRUG
    a blood pressure lowering drug, oral dose

Study Details

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.

Key Dates

Start date
Nov 18, 2021
Status verified
Aug 2023
Primary completion
Jan 15, 2022
Completion
Jan 15, 2022

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 10 mg [14C]-bexdrostat
    single oral dose of 10 mg baxdrostat containing 100 μCi of \[14C\] baxdrostat

Primary Outcome Measure

Total radioactivity recovery in urine and feces following administration of [14C] baxdrostat. [ Time Frame: 1 to 15 days after dosing ]

Locations (1)

FacilityCityStateZIPSite coordinators
Labcorp Clinical Research UnitMadisonWisconsin53704-

Find similar trials in Madison, WI

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Labcorp Clinical Research Unit· Madison, WI

Related Studies