Trials / Completed
CompletedNCT03066687
A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants
Randomized, Open-Label, 2-Way Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The primary purpose of this study is to evaluate the effect of food on the relative bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Erdafitinib | Erdafitinib 9 mg (provided as one 4-mg tablet \[G-024\] and one 5-mg tablet \[G-025\]) will be administered orally on Day 1 in each Treatment Period of assigned sequence. |
Timeline
- Start date
- 2017-03-14
- Primary completion
- 2017-05-12
- Completion
- 2017-05-12
- First posted
- 2017-02-28
- Last updated
- 2017-06-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03066687. Inclusion in this directory is not an endorsement.