AZD9833 for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Long Beach, CA
Healthy Subjects (HS)
AZD9833 - Drug
Eligibility
18+
Female
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Study Summary

This study will be a fixed sequence drug-drug interaction study in healthy postmenopausal females, conducted at multiple study sites.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 14 Secondary · Reporting Duration: From Screening until Post study (5 to 7 days post final dose) (assessed up to 6 months)

Day 5
Area under the plasma concentration-curve from zero to 24 hours post dose (AUC0-24) for celecoxib
Day 4
AUCinf for AZD9833 and free dabigatran
AUClast for AZD9833 and free dabigatran
Apparent total body clearance from plasma after extravascular administration (CL/F) for AZD9833 and free dabigatran
Apparent volume of distribution based on terminal phase (Vz/F) for AZD9833 and free dabigatran
Area under plasma concentration-time curve in the dose interval (AUCt) for AZD9833 and free dabigatran
Cmax for AZD9833 and free dabigatran
Half-life associated with terminal slope of a semi-logarithmic concentration-time curve (t½λz) for AZD9833 and free dabigatran
Time to reach maximum observed concentration (tmax) for AZD9833 and free dabigatran
Day 5
Area under plasma concentration time curve from zero to infinity (AUCinf) of midazolam, omeprazole, total dabigatran, and celecoxib
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) of midazolam, omeprazole, total dabigatran, and celecoxib
CL/F for midazolam, omeprazole, total dabigatran, and celecoxib
Maximum observed plasma concentration (Cmax) of midazolam, omeprazole, dabigatran etexilate and celecoxib
Vz/F for midazolam, omeprazole, total dabigatran, and celecoxib
tmax for midazolam, omeprazole, total dabigatran, and celecoxib
t½λz for midazolam, omeprazole, total dabigatran, and celecoxib
Month 6
Number of participants with Adverse Events (AEs)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Arm A (midazolam and omeprazole)
1 of 3
Arm C (Celecoxib)
1 of 3
Arm B (Dabigatran etexilate)
1 of 3
Experimental Treatment

59 Total Participants · 3 Treatment Groups

Primary Treatment: AZD9833 · No Placebo Group · Phase 1

Arm A (midazolam and omeprazole)Experimental Group · 3 Interventions: Omeprazole, Midazolam, AZD9833 · Intervention Types: Drug, Drug, Drug
Arm C (Celecoxib)Experimental Group · 2 Interventions: Celecoxib, AZD9833 · Intervention Types: Drug, Drug
Arm B (Dabigatran etexilate)Experimental Group · 2 Interventions: Dabigatran Etexilate, AZD9833 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omeprazole
2006
Completed Phase 4
~940
Celecoxib
2002
Completed Phase 3
~1740
Midazolam
2018
Completed Phase 4
~1920
Dabigatran Etexilate
2017
Completed Phase 4
~820

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from screening until post study (5 to 7 days post final dose) (assessed up to 6 months)
Closest Location: Research Site · Long Beach, CA
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1900First Recorded Clinical Trial
311 TrialsResearching Healthy Subjects (HS)
2957 CompletedClinical Trials

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,935 Previous Clinical Trials
91,865,457 Total Patients Enrolled
271 Trials studying Healthy Subjects (HS)
35,913 Patients Enrolled for Healthy Subjects (HS)

Eligibility Criteria

Age 18+ · Female Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must not take warfarin or phenytoin (and other coumarin-derived vitamin K antagonist anticoagulants) during study, and for 2 weeks after last administration of IMP.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.