Clinical trial · Interventional
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
A Phase 1, Multi-center, Open-label, 3-arm, Fixed Sequence Study to Assess the Effect of Co-administration of AZD9833 on the Pharmacokinetics of Midazolam (CYP3A4/5 Substrate), of Omeprazole (CYP2C19 Substrate), of Celecoxib (CYP2C9 Substrate) and of Dabigatran Etexilate (P-gp Transporter Substrate) in Healthy Postmenopausal Female Volunteers
NCT05438303CI-TRIAL-00063170completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will be a fixed sequence drug-drug interaction study in healthy postmenopausal females, conducted at multiple study sites
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Volunteers | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD9833 | Drug | Camizestrant | ALIAS |
| Celecoxib | Drug | Celecoxib | ALIAS |
| Dabigatran Etexilate | Drug | — | UNRESOLVED |
| Midazolam | Drug | — | UNRESOLVED |
| Omeprazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A (midazolam and omeprazole)
- description
- Participants will receive single oral doses of midazolam and omeprazole together (Day 1 of Treatment Periods 1 and 3) and repeated doses of AZD9833 (Days 1 to 5 of Treatment Period 2 and Day 1 of Treatment Period 3)
- interventionNames
- Drug: AZD9833
- Drug: Midazolam
- Drug: Omeprazole
- type
- EXPERIMENTAL
- label
- Arm B (Dabigatran etexilate)
- description
- Participants will receive single oral doses of dabigatran etexilate (Day 1 of Treatment Periods 1 and 2) and single oral dose of AZD9833 (Day 1 of Treatment Period 2)
- interventionNames
- Drug: AZD9833
- Drug: Dabigatran Etexilate
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.