Trials / Completed
CompletedNCT04534699
Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment
A Phase 1, Open Label, Nonrandomized, Single-dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of KBP-5074 in Subjects With Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- KBP Biosciences · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KBP-5074 | KBP-5074 tablet |
Timeline
- Start date
- 2020-08-27
- Primary completion
- 2020-11-19
- Completion
- 2020-11-19
- First posted
- 2020-09-01
- Last updated
- 2025-12-16
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04534699. Inclusion in this directory is not an endorsement.