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

Study identifier:D6970C00006

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

An Open-label, Fixed Sequence Study to Assess the Effect of Multiple Doses of Baxdrostat on the Pharmacokinetics of Single Doses of Combined Oral Ethinyl Estradiol and Levonorgestrel in Healthy Female Participants of Non-childbearing Potential.

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

EE/LNG, Baxdrostat

Sex

Female

Estimated Enrollment

Study type

Interventional

Age

35 Years - 75 Years

Date

Study Start Date: 01 Nov 2024

Estimated Primary Completion Date: 17 Jan 2025

Estimated Study Completion Date: 17 Jan 2025

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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:
(a) Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range (Follicular Stimulating Hormone (FSH) > 40 mIU/mL).
(b) Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
• Have a Body Mass Index (BMI) between 18 and 30 kg/m2
-

Exclusion Criteria

• History of any clinically important disease or disorder which, in the opinion of the Investigator
• History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Sex hormone therapy within one month before study.
• History of drug-related hepatic toxicity.
• History or family history of potential risk of arterial and venous thromboembolic events (eg, factor V Leiden mutation).
• History of cardiovascular risk (eg, history of myocardial infarction).
• Any laboratory values with the following deviations at the Screening Visit and Study Day -1 (admission to Clinical Unit).
• Any positive result on screening for serum HBsAg, HBcAb, HCV or HIV.
• History of any treatment with QT prolongation drugs.
• Current smokers or know history of alcohol or drug abuse.
• History or ongoing severe allergy/hypersensitivity.
• An increased risk for developing SAEs or a contraindication associated with administration of EE, or LNG such as history of thrombosis or thromboembolism, presence of estrogen dependent tumors, hypertension, migraines, and liver disease.
• Participants treated with strong CYP3A4 inhibitors or inducers within 3 months or longer (5 half-lives) prior to first administration of IMP in this study.
• Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
• Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives (whichever is longest) of the first administration of IMP in this study.
• Participants who are vegans or have medical dietary restrictions and vulnerable participants.

No locations available

Arms	Assigned Interventions
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).	Drug: EE/LNG EE/LNG tablet will be administered orally.
Experimental: Period 2: Baxdrostat Participants will self-administer the baxdrostat tablet once a day from Day 6 to Day 16.	Drug: Baxdrostat Baxdrostat tablet will be administered orally.
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).	Drug: EE/LNG EE/LNG tablet will be administered orally. Drug: Baxdrostat Baxdrostat tablet will be administered orally.

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]