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Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone

NCT06388616 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-11-12

No results posted yet for this study

Summary

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group.

Conditions

  • Hepatic Impairment

Interventions

DRUG

Balcinrenone

50 mg, Immediate release capsule to be taken orally.

Sponsors & Collaborators

Principal Investigators

  • Thomas C Marbury, M.D. · Servico Integrado de Tecnicas Endovasculares

  • Eric J Lawitz, M.D. · Servico Integrado de Tecnicas Endovasculares

  • Juan C Rondon, M.D. · Servico Integrado de Tecnicas Endovasculares

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-05-02
Primary Completion
2024-09-05
Completion
2024-09-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT06388616 on ClinicalTrials.gov