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NCT03291288 · ClinicalTrials.gov registry record · Phase 1
Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)
A Phase 1 study of Drug Interaction Potential, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 11
- Study locations
NCT03291288: Completed Phase 1 study of Drug Interaction Potential, sponsored by Daiichi Sankyo.
NCT03291288 is a Phase 1 study of Drug Interaction Potential that has completed, run by Daiichi Sankyo. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03291288, a Phase 1 study of Drug Interaction Potential, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 11
- Study locations
Study 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.
Primary Outcome
Plasma samples for midazolam were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 hours (h) (±10 minutes up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Pexidartinib
- DRUG Tolbutamide
Study Locations (11)
Other
- Leids Universitair Medisch Centrum - Leiden
- Christchurch Hospital NZ - Christchurch
- National Taiwan University Hospital - Taipei
Arizona
- HonorHealth - Scottsdale
- University of Arizona - Tucson
California
- Stanford University - Palo Alto
Kansas
- University of Kansas Cancer Center - Westwood
Massachusetts
- Dana-Farber Cancer Institute - Boston
Michigan
- Karmanos Cancer Center - Detroit
New York
- Northwell Health - Lake Success
Texas
- Mary Crowley Cancer Research - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2018-02-26 |
| Est. Completion | 2021-04-16 |
| Phase | Phase 1 |
What the finished NCT03291288 record still lists
NCT03291288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Drug Interaction Potential appearing as the primary indexed condition, and to 3 interventions - of which Midazolam is the first listed.
NCT03291288 lists 11 locations in 8 states (Other, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT03291288 about?
NCT03291288 is a clinical study titled "Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)". 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...
What is the current status of trial NCT03291288?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2018-02-26. Estimated completion is 2021-04-16.
What conditions does trial NCT03291288 study?
This clinical trial studies the following conditions: Drug Interaction Potential.
What interventions are being tested in trial NCT03291288?
The interventions under investigation include: Midazolam (DRUG), Pexidartinib (DRUG), Tolbutamide (DRUG).
Who is sponsoring clinical trial NCT03291288?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03291288 being conducted?
This trial has 11 study locations across Arizona, California, Kansas, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03291288's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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