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

Study identifier:D8532C00004

ClinicalTrials.gov identifier:NCT05438303

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD9833, Midazolam, Omeprazole, Dabigatran Etexilate, Celecoxib

Sex

Female

Actual Enrollment

59

Study type

Interventional

Age

50 Years - 70 Years

Date

Study Start Date: 13 Jun 2022
Primary Completion Date: 13 Dec 2022
Study Completion Date: 13 Dec 2022

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Jan 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria