Assessing the effect of multiple doses of zibotentan on the pharmacokinetics of single doses of combined oral contraceptives in healthy female participants of non-childbearing potential.

Study identifier:D4325C00006

ClinicalTrials.gov identifier:NCT05505162

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An Open-Label, Single-Sequence Study to Assess the Effect of Multiple Doses of Zibotentan on the Pharmacokinetics of Single Doses of Combined Oral Ethinyl Estradiol and Levonorgestrel in Healthy Female Participants of Non-Child-Bearing Potential

Medical condition

Healthy Female Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Zibotentan, EE/LNG

Sex

Female

Actual Enrollment

24

Study type

Interventional

Age

35 Years - 75 Years

Date

Study Start Date: 24 Aug 2022
Primary Completion Date: 10 Jan 2023
Study Completion Date: 10 Jan 2023

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria