Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment

Part of paid clinical trials in Rialto, California.

Sponsor
AstraZeneca
Study ID
NCT05961397
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • baxdrostat — DRUG
    single oral dose of baxdrostat 10 mg

Study Details

The goal of this Phase 1, open-label, single-dose, parallel-group study is to evaluate the pharmacokinetics (PK) of a single 10-mg oral dose of baxdrostat in subjects with varying degrees of hepatic function. The main objectives are to: * To assess the safety and tolerability of baxdrostat following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function; and * To characterize the PK of baxdrostat following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function. Participants were administered a single 10-mg oral dose of baxdrostat in the fasted state the morning of Day 1. Plasma samples were drawn at various timepoints. Safety assessments included adverse events, vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory evaluations, and physical examinations. Twenty subjects in 2 groups based on the Child-Pugh classification in the protocol at screening: up to 10 subjects in the normal hepatic function group and up to 10 subjects in the moderate hepatic impairment group. Twenty subjects entered and completed the study.

Key Dates

Start date
Aug 10, 2021
Status verified
Aug 2023
Primary completion
Apr 15, 2022
Completion
Apr 15, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Normal hepatic function group
    Subjects with normal hepatic function
  • Experimental: Moderate hepatic impairment group
    Subjects with a Child-Pugh score of 7 to 9 (Category B) at screening

Primary Outcome Measure

Incidence of treatment emergent adverse events following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function. [ Time Frame: up to 72 hours post-dose ]

Locations (5)

FacilityCityStateZIPSite coordinators
Inland Empire Clinical TrialsRialtoCalifornia92377-
Advanced Pharma CRMiamiFlorida33147-
Orlando Clinical Research CenterOrlandoFlorida32809-
Alliance for Multispecialty ResearchKnoxvilleTennessee37920-
American Research Corporation at the Texas Liver InstituteSan AntonioTexas78215-

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