MedTrace Logo

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

NCT05961397 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-08-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

baxdrostat

single oral dose of baxdrostat 10 mg

Sponsors & Collaborators

Principal Investigators

  • Kimberly Cruz, MD · Advanced Pharma CR

  • William B Smith,, MD · Alliance for Multispecialty Research

  • Zeid Kayali, MD · Inland Empire Clinical Trials

  • Thomas Marbury, MD · Orlando Clinical Research Center

  • Eric Lawitz, MD · American Research Corporation at the Texas Liver Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-08-10
Primary Completion
2022-04-15
Completion
2022-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05961397 on ClinicalTrials.gov