Healthy ParticipantsPhase 1NCT06657105
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
A Phase 1 study testing EE/LNG and Baxdrostat in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- EE/LNG and Baxdrostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 3 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 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).
- 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
Who cannot join
- 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).
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- EE/LNG, Baxdrostat
- Keywords
- Baxdrostat, Aldosterone, Ethinyl estradiol/ Levonorgestrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EE/LNGDrug
EE/LNG tablet will be administered orally.
BaxdrostatDrug
Baxdrostat tablet will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: EE/LNG |
| Period 2: Baxdrostat | Experimental | Participants will self-administer the baxdrostat tablet once a day from Day 6 to Day 16. Receives: Drug: Baxdrostat |
| 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). Receives: Drug: EE/LNG; Drug: Baxdrostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under concentration-time curve from time zero to infinity (AUCinf)
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.
Measured: EE: Up to Day 21, LNG: Up to Day 23
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
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.
Measured: EE: Up to Day 21, LNG: Up to Day 23
Maximum observed drug concentration (Cmax)
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.
Measured: EE: Up to Day 21, LNG: Up to Day 23
Secondary outcomes (12)
Maximum observed drug concentration (Cmax) of EE/LNG
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
Measured: 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
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
Measured: EE: Up to Day 21, LNG: Up to Day 23
Area under concentration-time curve from time zero to infinity (AUCinf) of EE/LNG
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
Measured: EE: Up to Day 21, LNG: Up to Day 23
Time to reach maximum observed concentration (tmax)
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
Measured: EE: Up to Day 21, LNG: Up to Day 23
Terminal elimination half-life (t1/2λz)
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
Measured: EE: Up to Day 21, LNG: Up to Day 23
Terminal rate constant (λz)
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
Measured: 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)
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
Measured: 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)
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
Measured: 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)
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
Measured: EE: Up to Day 21; LNG: Up to Day 23
Number of participants with adverse event (AEs)
To examine the safety and tolerability of baxdrostat alone and in combination with combined oral EE and LNG.
Measured: From screening (Day -28 to Day -2) to 8.5 weeks
Maximum observed drug concentration (Cmax) of Baxdrostat
To assess the PK of baxdrostat in healthy female participants of non-childbearing potential.
Measured: Baxdrostat: Day 18 to Day 22
Observed lowest concentration before the next dose is administered (Day 22 pre-dose) (Ctrough)
To assess the PK of baxdrostat in healthy female participants of non-childbearing potential.
Measured: Baxdrostat: Day 18 to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Nov 2024
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657105
- Sponsor's protocol ID
- D6970C00006
- Status last verified
- Feb 2025
- First submitted
- 23 Oct 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06657105
- Acronym / sponsor ID
- D6970C00006
- Conditions
- Healthy Participants
- Keywords
- Baxdrostat, Aldosterone, Ethinyl estradiol/ Levonorgestrel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Period 1: Ethinyl estradiol/Levonorgestrel (EE/LNG) | Experimental | Drug: EE/LNGParticipants 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 | Drug: BaxdrostatParticipants will self-administer the baxdrostat tablet once a day from Day 6 to Day 16. |
| Period 3: Baxdrostat + EE/LNG | Experimental | Drug: EE/LNG, Drug: BaxdrostatParticipants 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). |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
- Have a Body Mass Index (BMI) between 18 and 30 kg/m2
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EE/LNGEE/LNG tablet will be administered orally. | Drug | Period 1: Ethinyl estradiol/Levonorgestrel (EE/LNG), Period 3: Baxdrostat + EE/LNG |
| BaxdrostatBaxdrostat tablet will be administered orally. | Drug | Period 2: Baxdrostat, Period 3: Baxdrostat + EE/LNG |
Primary outcome
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.
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.
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.
12 secondary outcomes
Maximum observed drug concentration (Cmax) of EE/LNG
Time frame: 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
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
Time to reach maximum observed concentration (tmax)
Time frame: 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
Terminal rate constant (λz)
Time frame: 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
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
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
Number of participants with adverse event (AEs)
Time frame: 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
Observed lowest concentration before the next dose is administered (Day 22 pre-dose) (Ctrough)
Time frame: Baxdrostat: Day 18 to Day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EE/LNG and Baxdrostat in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under concentration-time curve from time zero to infinity (AUCinf) (time frame: EE: Up to Day 21, LNG: Up to Day 23). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.