Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 small molecule drug candidate being developed by AstraZeneca PLC. It combines ethinyl estradiol and levonorgestrel, and it has been studied in healthy female participants of non-childbearing potential. The program is in Phase 1 development, and no patient indication has been disclosed for it.
EE/LNG is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 1 study of the combination in healthy female volunteers. AstraZeneca is the developer associated with this asset.
EE/LNG is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed for the program. It is an investigational drug candidate and is not described as approved by the FDA.
EE/LNG has been evaluated in one Phase 1 trial, NCT06657105, titled 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. The trial was completed, enrolled 22 participants, and was conducted in the United States.
The completed Phase 1 trial, NCT06657105, investigated the pharmacokinetics of ethinyl estradiol and levonorgestrel when given alone and in combination with baxdrostat. It enrolled 22 healthy female participants of non-childbearing potential, aged 35 years and older, in the United States. The study was controlled but not randomized or double blinded.