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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT05438303

Run by

AstraZeneca

People needed

59

Starts

2022-06-13

Expected to finish

2022-12-13

Last updated by the study team

2023-01-12

Who can join

Age: 50 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Long Beach, California, United States
• Research Site — Berlin, New Jersey, United States

Full record on ClinicalTrials.gov

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