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EE/LNG · 1 trial · 1 indication
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...
EE/LNG is a combination of ethinyl estradiol and levonorgestrel being studied in healthy female participants. It is currently in Phase 1 clinical development as an investigational small molecule. The drug is being evaluated for its pharmacokinetics when given alone and in combination with baxdrostat.
EE/LNG is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical research on this combination of ethinyl estradiol and levonorgestrel in healthy participants.
EE/LNG is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 study has been completed, involving 22 healthy female participants.
EE/LNG has one completed clinical trial, NCT06657105, which investigated the pharmacokinetics of ethinyl estradiol and levonorgestrel when given alone and in combination with baxdrostat in healthy females of non-childbearing potential. The study was conducted in the United States.
EE/LNG is the combination of ethinyl estradiol and levonorgestrel, two components that are being studied together. The drug is being evaluated for its pharmacokinetic profile in healthy participants.