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NCT03901313 · ClinicalTrials.gov registry record · Phase 1
Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Volunteers
A Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03901313 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 24 participants.
The verdict
NCT03901313, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
All participants in this study are healthy volunteers. Throughout the study, healthy volunteers will have physical exams, electrocardiograms and clinical laboratory tests. The study staff will keep track of symptoms, diet, and what medications they are taking. Each participant will get all three treatments (A, B and C). Only the order in which they receive them will be different. There are six groups based on the order: ABC, ACB, BAC, BCA, CAB, or CBA. Participants have an equal chance of being assigned to any of these groups. For each treatment period, participants will: * fast overnight * receive the assigned treatment with or without food * have a small tube of blood drawn prior to treatment * after dosing, additional blood samples will be drawn at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours * have a break from treatment for 6 days between each treatment period All participants must reside in the clinic for a total of 20 days.
Interventions
- DRUG Treatment A - 400 mg Fasting
- DRUG Treatment B - 400 mg Fed
- DRUG Treatment C - 200 mg Fed
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2019-05-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03901313
The ClinicalTrials.gov registry entry for NCT03901313 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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 0 conditions, and to 3 interventions - of which Treatment A - 400 mg Fasting is the first listed.
NCT03901313 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03901313 about?
NCT03901313 is a clinical study titled "Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Volunteers". All participants in this study are healthy volunteers. Throughout the study, healthy volunteers will have physical exams, electrocardiograms and clinical laboratory tests. The study staff will keep track of symptoms, diet, and what medications they are taking. Each participant will get all three t...
What is the current status of trial NCT03901313?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-04-01. Estimated completion is 2019-05-22.
What interventions are being tested in trial NCT03901313?
The interventions under investigation include: Treatment A - 400 mg Fasting (DRUG), Treatment B - 400 mg Fed (DRUG), Treatment C - 200 mg Fed (DRUG).
Who is sponsoring clinical trial NCT03901313?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
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