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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 is a Phase 1 study of Drug Interaction Potential that has completed, run by Daiichi Sankyo. The registered enrollment target is 32 participants. The trial reports 11 study locations across 8 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03291288
The ClinicalTrials.gov registry entry for NCT03291288 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.
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 reports 11 study locations spanning 8 distinct geographic areas - top geographies include 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.
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