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COMPLETED Phase 1

Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers

NCT02224053 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 136 participants
Start Date 2014-09
Est. Completion 2015-01
Phase Phase 1

Sponsor

AstraZeneca

1,053 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02224053

The ClinicalTrials.gov registry entry for NCT02224053 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,053 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02224053 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Kansas, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02224053?

This trial is sponsored by AstraZeneca, which has 1,053 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial