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

February 6, 2025 updated by: AstraZeneca

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label, 3-period fixed sequence study conducted at a single Clinical Unit.

The study will comprise of:

  • A Screening period of maximum 28 days.
  • Period 1: - From Day -1 to Day 5.
  • Period 2: -From Day 6 to Day 16
  • Period 3: - From Day 17 to Day 23.
  • A Final Follow-up Visit, 7 (± 2) days after the last PK sample in Period 3.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Brooklyn, Maryland, United States, 21225
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 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).
    2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: Baxdrostat
Baxdrostat tablet will be administered orally.
Drug: EE/LNG
EE/LNG tablet will be administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area under concentration-time curve from time zero to infinity (AUCinf)
Time Frame: EE: Up to Day 21, LNG: Up to Day 23
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.
EE: Up to Day 21, LNG: Up to Day 23
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time Frame: EE: Up to Day 21, LNG: Up to Day 23
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.
EE: Up to Day 21, LNG: Up to Day 23
Maximum observed drug concentration (Cmax)
Time Frame: EE: Up to Day 21, LNG: Up to Day 23
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.
EE: Up to Day 21, LNG: Up to Day 23

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum observed drug concentration (Cmax) of EE/LNG
Time Frame: EE: Up to Day 21, LNG: Up to Day 23
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
EE: Up to Day 21, LNG: Up to Day 23
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of EE/LNG
Time Frame: EE: Up to Day 21, LNG: Up to Day 23
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
EE: Up to Day 21, LNG: Up to Day 23
Area under concentration-time curve from time zero to infinity (AUCinf) of EE/LNG
Time Frame: EE: Up to Day 21, LNG: Up to Day 23
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
EE: Up to Day 21, LNG: Up to Day 23
Time to reach maximum observed concentration (tmax)
Time Frame: EE: Up to Day 21, LNG: Up to Day 23
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
EE: Up to Day 21, LNG: Up to Day 23
Terminal elimination half-life (t1/2λz)
Time Frame: EE: Up to Day 21, LNG: Up to Day 23
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
EE: Up to Day 21, LNG: Up to Day 23
Terminal rate constant (λz)
Time Frame: EE: Up to Day 21, LNG: Up to Day 23
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
EE: Up to Day 21, LNG: Up to Day 23
Ratio of EE or LNG to EE (alone) or LNG (alone) based on AUCinf (RAUCinf)
Time Frame: EE: Up to Day 21, LNG: Up to Day 23
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
EE: Up to Day 21, LNG: Up to Day 23
Ratio of EE or LNG to EE (alone) or LNG (alone) based on AUClast (RAUClast)
Time Frame: EE: Up to Day 21; LNG: Up to Day 23
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
EE: Up to Day 21; LNG: Up to Day 23
Ratio of EE or LN to EE (alone) or LNG (alone) based on Cmax (RCmax)
Time Frame: EE: Up to Day 21; LNG: Up to Day 23
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
EE: Up to Day 21; LNG: Up to Day 23
Number of participants with adverse event (AEs)
Time Frame: From screening (Day -28 to Day -2) to 8.5 weeks
To examine the safety and tolerability of baxdrostat alone and in combination with combined oral EE and LNG.
From screening (Day -28 to Day -2) to 8.5 weeks
Maximum observed drug concentration (Cmax) of Baxdrostat
Time Frame: Baxdrostat: Day 18 to Day 22
To assess the PK of baxdrostat in healthy female participants of non-childbearing potential.
Baxdrostat: Day 18 to Day 22
Observed lowest concentration before the next dose is administered (Day 22 pre-dose) (Ctrough)
Time Frame: Baxdrostat: Day 18 to Day 22
To assess the PK of baxdrostat in healthy female participants of non-childbearing potential.
Baxdrostat: Day 18 to Day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D6970C00006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-leveldata from AstraZeneca group of companies sponsored clinical trials via therequest portal Vivli.org. All requests will be evaluated as per the AZ disclosurecommitment:https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes",indicates that AZ are accepting requests for IPD, but this does not mean allrequests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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