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NCT03649165 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03649165 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 24 participants.
The verdict
NCT03649165, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study will evaluate bioavailability and food effect of selumetinib (AZD6244) in healthy male participants. A total of 24 healthy male participants will be included to ensure at least 20 evaluable participants. The study is divided in 2 study parts; the same participants will participate in both parts of the study. Part 1 of the study is to investigate the pharmacokinetics (PK) of the selumetinib granule compared to the PK of selumetinib capsule, when administered with water under the fasted conditions. Part 2 of the study is to investigate the PK of selumetinib granule and capsule under fed conditions. Participants will also receive a single 500 mg dose of acetaminophen at the same time as selumetinib administration.
Interventions
- DRUG Acetaminophen
- DRUG Treatment A
- DRUG Treatment B
- DRUG Treatment C
- DRUG Treatment D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-09-05 |
| Est. Completion | 2018-10-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03649165
The ClinicalTrials.gov registry entry for NCT03649165 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 AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT03649165 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03649165 about?
NCT03649165 is a clinical study titled "A Study to Evaluate Bioavailability and Food Effect of Selumetinib (AZD6244) in Healthy Male Participants". This study will evaluate bioavailability and food effect of selumetinib (AZD6244) in healthy male participants. A total of 24 healthy male participants will be included to ensure at least 20 evaluable participants. The study is divided in 2 study parts; the same participants will participate in both...
What is the current status of trial NCT03649165?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-09-05. Estimated completion is 2018-10-21.
What interventions are being tested in trial NCT03649165?
The interventions under investigation include: Acetaminophen (DRUG), Treatment A (DRUG), Treatment B (DRUG), Treatment C (DRUG), Treatment D (DRUG).
Who is sponsoring clinical trial NCT03649165?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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