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NCT02224053 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers
A Phase 1 study of Healthy Volunteer, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 136
- Enrollment target
- 2
- Study locations
NCT02224053: Completed Phase 1 study of Healthy Volunteer, sponsored by AstraZeneca.
NCT02224053 is a Phase 1 study of Healthy Volunteer that has completed, run by AstraZeneca. The registered enrollment target is 136 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (32% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02224053, a Phase 1 study of Healthy Volunteer, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 136 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase 1, open-label, 2-period fixed sequence design to evaluate the interaction of AZD9291 with omeprazole in approximately 50 healthy, adult male volunteers. Volunteers will receive Treatment A (AZD9291 and omeprazole) in Period 1 and Treatment B (AZD9291 only) in Period 2. The dose of AZD9291 in Period 1 and the dose of AZD9291 in Period 2 will be separated by a washout of at least 21 days (the washout will not be more than 5 weeks). The study will be performed at up to 2 sites in the USA and will assess the effect of omeprazole (proton pump inhibitor) on AZD9291 exposure
Primary Outcome
Area under the plasma concentration-time curve from zero to infinity for AZD9291
Conditions Studied
Interventions
- PROCEDURE Pharmacokinetic sampling - AZD9291
- DRUG AZD9291 tablet dosing
- DRUG Omeprazole tablet dosing
- PROCEDURE Pharmacokinetic sampling - AZ5140 and AZ7550
Study Locations (2)
Kansas
- Research Site - Overland Park
Minnesota
- Research Site - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2014-09 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT02224053 record still lists
NCT02224053 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (32% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 4 interventions - of which Pharmacokinetic sampling - AZD9291 is the first listed.
NCT02224053 reports a single indexed study location in Kansas, Minnesota.
Frequently Asked Questions
What is clinical trial NCT02224053 about?
NCT02224053 is a clinical study titled "Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers". This is a Phase 1, open-label, 2-period fixed sequence design to evaluate the interaction of AZD9291 with omeprazole in approximately 50 healthy, adult male volunteers. Volunteers will receive Treatment A (AZD9291 and omeprazole) in Period 1 and Treatment B (AZD9291 only) in Period 2. The dose of AZ...
What is the current status of trial NCT02224053?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2014-09. Estimated completion is 2015-01.
What conditions does trial NCT02224053 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT02224053?
The interventions under investigation include: Pharmacokinetic sampling - AZD9291 (PROCEDURE), AZD9291 tablet dosing (DRUG), Omeprazole tablet dosing (DRUG), Pharmacokinetic sampling - AZ5140 and AZ7550 (PROCEDURE).
Who is sponsoring clinical trial NCT02224053?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02224053 being conducted?
This trial has 2 study locations across Kansas, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02224053's enrollment target sits among peer trials
136 27th of 112 higher than 86 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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.
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