Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT05438303
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT05438303
Study Brief:
Protocol Section:
NCT05438303