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.
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
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
22
EE/LNG tablet will be administered orally.
Baxdrostat tablet will be administered orally.
Research Site
Brooklyn, Maryland, United States
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.
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)
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.
Time frame: 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.
Time frame: EE: Up to Day 21, LNG: Up to Day 23
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.
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
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
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
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
Time frame: EE: Up to Day 21, LNG: Up to Day 23
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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.
Time frame: 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.
Time frame: 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.
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)
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
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)
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
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)
To describe the PK of a single dose of combined oral EE and LNG in healthy females of non-childbearing potential.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baxdrostat: Day 18 to Day 22