Baxdrostat Bioavailability and Bioequivalence Study

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
AstraZeneca
Study ID
NCT05963009
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 11, 2020
Status verified
Aug 2023
Primary completion
Apr 29, 2020
Completion
Apr 29, 2020

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Baxdrostat oral solution
    5 mg CIN-107 oral solution in a fasted state
  • Experimental: Baxdrostat tablet (fasted state)
    5 mg CIN-107 tablet(s) in a fasted state
  • Experimental: Baxdrostat tablet (fed state)
    5 mg CIN-107 tablet(s) in a fed state (standard high fat meal)

Primary Outcome Measure

Incidence of treatment emergent adverse events following single oral doses of CIN-107 tablet and oral solution. [ Time Frame: 0 to 23 days after dosing ]

Locations (1)

FacilityCityStateZIPSite coordinators
MedpaceCincinnatiOhio45227-

Find similar trials in Cincinnati, OH

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Medpace· Cincinnati, OH

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