Trials / Completed
CompletedNCT03816631
A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment
A Phase 1, Open-label, Single-dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Orally Administered Pimodivir in Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Janssen-Cilag International NV · Industry
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Accepted
Summary
The purpose is to evaluate the pharmacokinetics (PK) of a single oral dose of 600 milligram (mg) pimodivir in adult participants with impaired hepatic function compared to adult participants with normal hepatic function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pimodivir | Participants will receive single oral dose of Pimodivir 600 mg (2\*300 mg tablets) under fasted condition on Day 1. |
Timeline
- Start date
- 2019-05-28
- Primary completion
- 2020-04-27
- Completion
- 2020-04-27
- First posted
- 2019-01-25
- Last updated
- 2025-02-03
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03816631. Inclusion in this directory is not an endorsement.