Study identifier:D4325C00006
ClinicalTrials.gov identifier:NCT05505162
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy Female Participants
Phase 1
Yes
Zibotentan, EE/LNG
Female
24
Interventional
35 Years - 75 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Zibotentan and EE/LNG Participants will receive two tablets of combined oral EE/LNG on Day 1 with PK samples obtained from pre-dose on Day 1 until post-dose on Day 6. Participants will receive two capsules of zibotentan orally QD from Day 6 to Day 14. From Day 15 until Day 19 participants will continue to receive two capsules of zibotentan QD administered orally. On Day 15, participants will receive two tablets of combined oral EE and LNG with PK samples obtained pre-dose on Day 15 until post-dose (Day 20). | - |