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.

Healthy Female Participants Clinical Trial

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

Status Completed

Clinical Trial Summary

A study to assess the Pharmacokinetics (PK) of combined oral ethinyl estradiol (EE) and levonorgestrel (LNG) in healthy female participants of non-child-bearing potential, when administered alone and in combination with multiple oral doses of zibotentan.

Clinical Trial Description

This is an open-label, single-sequence study conducted at a single study center.

The study will comprise of the following:

• A Screening Period (Visit 1) of maximum 28 days (Day -28 to Day -2).

• Treatment Period 1/Day 1 to Day 5 (in-house stay): Participants will check in at the clinical unit on Day -1 and will be resident at the clinical unit until Day 6.

• Treatment Period 2/Day 6 to Day 14 (home): Outpatient period.

• Treatment Period 3/Day 15 to Day 20 (in-house stay): On the evening of Day 14, the participants will check in at the clinical unit and will be resident at the clinical unit until Day 20.

• A follow-up visit (Day 27) will be conducted 7 days (±2 days) after the last PK sample collection (120 hours post-dose [Day 20]).

Participants will receive two tablets of EE/LNG on days 1 and 15 and 2 capsules of zibotentan on days 6-19. ;

Related Conditions & MeSH terms

• Healthy Female Participants

• NCT number: NCT05505162
• Study type: Interventional
• Source: AstraZeneca
• Status: Completed
• Phase: Phase 1
• Start date: August 24, 2022
• Completion date: January 10, 2023