Study identifier:D8532C00004
ClinicalTrials.gov identifier:NCT05438303
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy Volunteers
Phase 1
Yes
AZD9833, Midazolam, Omeprazole, Dabigatran Etexilate, Celecoxib
Female
59
Interventional
50 Years - 70 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other
Verified 01 Jan 2023 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm A (midazolam and omeprazole) 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) | Drug: AZD9833 AZD9833 tablets will be administered orally once daily on Days 1 - Day 5 (Treatment Period 2) and Day 1 (Treatment Period 3) for participants recruited to Arms A and C and Day 1 for those in Arm B Drug: Midazolam Midazolam will be administered orally as a syrup once on Day 1 of Treatment Periods 1 and 3; administered together with Omeprazole Drug: Omeprazole An Omeprazole capsule will be administered once on Day 1 of Treatment Periods 1 and 3; administered together with Midazolam |
Experimental: Arm B (Dabigatran etexilate) 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) | Drug: AZD9833 AZD9833 tablets will be administered orally once daily on Days 1 - Day 5 (Treatment Period 2) and Day 1 (Treatment Period 3) for participants recruited to Arms A and C and Day 1 for those in Arm B Drug: Dabigatran Etexilate A Dabigatran Etexilate capsule will be administered once on Day 1 of Treatment Periods 1 and 2 |
Experimental: Arm C (Celecoxib) Participants will receive single oral doses of celecoxib (Day 1 of Treatment Periods 1 and 3) and repeated oral doses of AZD9833 (Days 1 to 5 of Treatment Period 2 and Day 1 of Treatment Period 3) | Drug: AZD9833 AZD9833 tablets will be administered orally once daily on Days 1 - Day 5 (Treatment Period 2) and Day 1 (Treatment Period 3) for participants recruited to Arms A and C and Day 1 for those in Arm B Drug: Celecoxib A Celecoxib capsule will be administered once on Day 1 of Treatment Periods 1 and 3 |