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Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment

NCT04534699 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-12-16

No results posted yet for this study

Summary

This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of KBP-5074.

Conditions

  • Moderate Hepatic Impairment
  • Healthy

Interventions

DRUG

KBP-5074

KBP-5074 tablet

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • KBP Biosciences

    lead INDUSTRY

Principal Investigators

  • James McCabe · KBP Biosciences

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
2020-08-27
Primary Completion
2020-11-19
Completion
2020-11-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04534699 on ClinicalTrials.gov