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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: Completed Phase 1 study, sponsored by AstraZeneca.
NCT03649165 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To compare the AUC/D of the new selumetinib granule formulation with selumetinib capsule formulation in fasted state.
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 |
What the finished NCT03649165 record still lists
NCT03649165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT03649165 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03649165's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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