Trials / Completed
CompletedNCT03291288
Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)
An Open-label, Single Sequence, Crossover Drug-drug Interaction Study Assessing the Effect of Pexidartinib on the Pharmacokinetics of CYP3A4 and CYP2C9 Substrates in Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study has two parts. Part 1 will evaluate how pexidartinib affects the way the body processes CYP3A4 and CYP2C9 substrates using midazolam and tolbutamide, respectively, as probe agents. Part 2 will test the efficacy and safety of pexidartinib treatment in various tumor types. In Part 2, the same participants will continue to receive pexidartinib twice daily. Participants will be allowed to continue using pexidartinib as long as the participant derives benefit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tolbutamide | Commercially available tolbutamide |
| DRUG | Midazolam | Commercially available midazolam |
| DRUG | Pexidartinib | Pexidartinib is formulated as opaque, white, 200-mg capsules |
Timeline
- Start date
- 2018-02-26
- Primary completion
- 2018-09-26
- Completion
- 2021-04-16
- First posted
- 2017-09-25
- Last updated
- 2021-05-14
- Results posted
- 2020-03-19
Locations
11 sites across 4 countries: United States, Netherlands, New Zealand, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03291288. Inclusion in this directory is not an endorsement.