Status:
COMPLETED
Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Volunteers
Eligibility:
FEMALE
50-70 years
Phase:
PHASE1
Brief Summary
This study will be a fixed sequence drug-drug interaction study in healthy postmenopausal females, conducted at multiple study sites
Detailed Description
Participants will be randomized to one of 3 treatment arms on Day 1 prior to Investigational Medicinal Product (IMP) administration: * Arm A: single oral doses of midazolam and omeprazole administere...
Eligibility Criteria
Inclusion
- Healthy postmenopausal female participants aged 50 to 70 years with suitable veins for cannulation or repeated venipuncture.
- Participants must be postmenopausal by fulfilling the following criterion:
- Have a Body mass index (BMI) between 19 and 35 kg/m\^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive as measured at screening.
- Must agree to not use warfarin or phenytoin (and other coumarin-derived vitamin K antagonist anticoagulants) during study, and for 2 weeks after last administration of IMP.
Exclusion
- History of any clinically significant disease or disorder as described by the Investigator.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Use of systemic estrogen-containing hormone replacement therapy within 6 months prior to first dose in the study.
- Have taken any proton pump inhibitors (omeprazole, lansoprazole, esomeprazole, pantoprazole, etc.) within 14 days of beginning study treatment (ie, first administration of omeprazole in Arm A.
- Have taken any drug with enzyme-inducing properties such as St John's Wort within 3 weeks of screening.
- Presence of any contraindication to the probe substrates omeprazole, midazolam, dabigatran or celecoxib per the United States Package Insert.
- Any of the following signs or confirmation of COVID-19 infection:
- Subject has a positive RT-PCR test for SARS-CoV-2 prior to randomization.
- Clinical signs and symptoms consistent with COVID-19 (eg, fever, dry cough, dyspnea, sore throat, fatigue) or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or at randomization.
- Subject has been previously hospitalized with COVID-19 infection within the last 12 months.
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2022
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT05438303
Start Date
June 13 2022
End Date
December 13 2022
Last Update
January 12 2023
Active Locations (2)
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1
Research Site
Long Beach, California, United States, 90806
2
Research Site
Berlin, New Jersey, United States, 08009