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

Part of paid clinical trials in Brooklyn, Maryland.

Sponsor
AstraZeneca
Study ID
NCT06657105
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
FEMALE
Age
35 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • EE/LNG — DRUG
    EE/LNG tablet will be administered orally.
  • Baxdrostat — DRUG
    Baxdrostat tablet will be administered orally.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Feb 2025
Primary completion
Feb 3, 2025
Completion
Feb 3, 2025

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Period 1: Ethinyl estradiol/Levonorgestrel (EE/LNG)
    Participants will receive oral dose of EE/LNG in the fasted state on Day ,1 followed by PK sampling of EE/LNG for 120 hours (EE 72 hours and LNG 120 hours).
  • Experimental: Period 2: Baxdrostat
    Participants will self-administer the baxdrostat tablet once a day from Day 6 to Day 16.
  • Experimental: Period 3: Baxdrostat + EE/LNG
    Participants will receive baxdrostat once daily on Day 17 to Day 22 and will receive EE+LNG in the fasted state on Day 18, followed by oral dose of EE/LNG PK sampling for 120 hours (EE=72 hours and LNG=120 hours).

Primary Outcome Measure

Area under concentration-time curve from time zero to infinity (AUCinf) [ Time Frame: EE: Up to Day 21, LNG: Up to Day 23 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteBrooklynMaryland21225-

Find similar trials in Brooklyn, MD

By research site
Research Site· Brooklyn, MD

Related Studies