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
NCT06657105 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2025-02-07
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.
Conditions
- Healthy Participants
Interventions
- DRUG
-
EE/LNG
EE/LNG tablet will be administered orally.
- DRUG
-
Baxdrostat
Baxdrostat tablet will be administered orally.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 35 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-11-01
- Primary Completion
- 2025-02-03
- Completion
- 2025-02-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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