Trials / Terminated
TerminatedNCT03587363
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib
A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
The primary purpose of the study is to characterize the single dose pharmacokinetic of erdafitinib in participants with impaired hepatic function relative to participants with normal hepatic function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Erdafitinib | Participants will receive 6 mg (2\*3 mg tablet) erdafitinib as a single oral dose on Day 1. Participants in Cohort 4 may receive a lower dose if warranted by preliminary safety and PK data from Cohorts 2 and 3. |
Timeline
- Start date
- 2018-12-06
- Primary completion
- 2020-12-22
- Completion
- 2020-12-22
- First posted
- 2018-07-16
- Last updated
- 2025-02-03
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03587363. Inclusion in this directory is not an endorsement.