Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE1 | COMPLETED | 22 | — | — | Nov 1, 2024 | Feb 3, 2025 | Feb 7, 2025 | 1 | United States |
To assess the effect of multiple doses of baxdrostat on the PK of a single dose of combined oral EE/LNG in healthy females of non-childbearing potential.
To assess the effect of multiple doses of baxdrostat on the PK of a single dose of combined oral EE/LNG in healthy females of non-childbearing potential.
To assess the effect of multiple doses of baxdrostat on the PK of a single dose of combined oral EE/LNG in healthy females of non-childbearing potential.
| Arm | Type | Description |
|---|---|---|
| Period 1: Ethinyl estradiol/Levonorgestrel (EE/LNG) | EXPERIMENTAL | 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). |
| Period 2: Baxdrostat | EXPERIMENTAL | Participants will self-administer the baxdrostat tablet once a day from Day 6 to Day 16. |
| Period 3: Baxdrostat + EE/LNG | EXPERIMENTAL | 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). |
| Name | Type | Description |
|---|---|---|
| EE/LNG | DRUG | EE/LNG tablet will be administered orally. |
| Baxdrostat | DRUG | Baxdrostat tablet will be administered orally. |
Inclusion Criteria: * Females must have a negative pregnancy test at the Screening Visit and Study Day -1 (admission to Clinical Unit) and must not be lactating and must be of non-childbearing potential, confirmed at Screening by fulfilling one of the following criteria: 1. Postmenopausal define...