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NCT03647202 · ClinicalTrials.gov registry record · Early Phase 1
Food Effects on Milademetan Pharmacokinetics in Healthy Participants
A Early Phase 1 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 18
- Enrollment target
NCT03647202 is a Early Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 18 participants.
The verdict
NCT03647202, a Early Phase 1 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The primary objectives of this trial are: * To evaluate the effect of a high-calorie, high-fat meal on the single-dose pharmacokinetics (PK) of milademetan * To evaluate the effect of a standard meal on the single-dose PK of milademetan The key secondary objective is to evaluate the safety and tolerability of single-dose milademetan in all treatments. The duration of the study for each individual participant will be approximately 8 weeks from the start of Screening (within 28 days prior to dosing of study drug on Day 1) through the final Follow-up visit or phone call. Participants will remain in the Clinical Research Unit (CRU) from Study Day -2 through Study Day 20 (a total of 22 days and 21 nights). Participants will receive 3 single doses of study drug (at least 1 week apart) over the course of 15 days. At the investigator's discretion, participants may be asked to return to the CRU 14 days (±2 days) after final dose of study drug for a follow-up visit. The end of the study is defined as the date of final follow-up visit of the last subject undergoing the study.
Interventions
- DRUG Milademetan Treatment A
- DRUG Milademetan Treatment B
- DRUG Milademetan Treatment C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-08-16 |
| Est. Completion | 2018-09-13 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03647202
The ClinicalTrials.gov registry entry for NCT03647202 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 18 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 Milademetan Treatment A is the first listed.
NCT03647202 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03647202 about?
NCT03647202 is a clinical study titled "Food Effects on Milademetan Pharmacokinetics in Healthy Participants". The primary objectives of this trial are: * To evaluate the effect of a high-calorie, high-fat meal on the single-dose pharmacokinetics (PK) of milademetan * To evaluate the effect of a standard meal on the single-dose PK of milademetan The key secondary objective is to evaluate the safety and tol...
What is the current status of trial NCT03647202?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 18 participants. The study started on 2018-08-16. Estimated completion is 2018-09-13.
What interventions are being tested in trial NCT03647202?
The interventions under investigation include: Milademetan Treatment A (DRUG), Milademetan Treatment B (DRUG), Milademetan Treatment C (DRUG).
Who is sponsoring clinical trial NCT03647202?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
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