NCT06657105

A Study to Investigate the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel When Given Alone and in Combination With Baxdrostat in Healthy Females of Non-childbearing Potential

An Open-label, Fixed Sequence Study to Assess the Effect of Multiple Doses of Baxdrostat on the Pharmacokinetics of Single Doses of Combined Oral Ethinyl Estradiol and Levonorgestrel in Healthy Female Participants of Non-childbearing Potential.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The main purpose of the study is to assess the effect of multiple doses of baxdrostat on the pharmacokinetics (PK) of a single dose of combined oral ethinyl estradiol (EE) and levonorgestrel (LNG). Safety and tolerability of baxdrostat will be assessed during the study.

Detailed description

This is an open-label, 3-period fixed sequence study conducted at a single Clinical Unit. The study will comprise of: * A Screening period of maximum 28 days. * Period 1: - From Day -1 to Day 5. * Period 2: -From Day 6 to Day 16 * Period 3: - From Day 17 to Day 23. * A Final Follow-up Visit, 7 (± 2) days after the last PK sample in Period 3.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	EE/LNG	EE/LNG tablet will be administered orally.
DRUG	Baxdrostat	Baxdrostat tablet will be administered orally.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-02-03
• Completion: 2025-02-03
• First posted: 2024-10-24
• Last updated: 2025-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study