Effect of multiple doses of BI 1358894 on the pharmacokinetics of ethinylestradiol and drospirenone in healthy women

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What is this study about?

The trial involves healthy women who normally use a combined oral contraceptive that contains ethinylestradiol and drospirenone, marketed as Yasmin®. A new oral medication identified as BI 1358894 is being tested to see whether it changes how much of the contraceptive hormone reaches the bloodstream.

The purpose of the study is to investigate the effect of multiple oral doses of the test drug on the pharmacokinetics of the contraceptive hormones. Participants will first take the contraceptive pill alone for several weeks, then, after a short break, they will take the same pill together with the test medication for another period, allowing comparison of hormone levels under the two conditions.

During the study, volunteers will visit the clinic several times for routine checks and blood draws to measure hormone concentrations. The term pharmacokinetics refers to how a drug is absorbed, distributed, metabolized, and eliminated by the body, while steady state describes the point at which the amount of drug taken equals the amount cleared, resulting in a stable level in the blood. All procedures are non‑invasive and the study duration for each participant spans a few months.

1 start of period 1 – take contraceptive tablet

you will receive a tablet that contains ethinylestradiol 0.03 mg and drospirenone 3 mg. both ingredients are hormones used in combined oral contraceptives.

the tablet is taken by mouth once each day. you will continue taking one tablet every day for the entire first period of the study as instructed by the study staff.

the purpose of this period is to establish the normal level of the contraceptive hormones in your blood before any other study drug is added.

2 clinic visits and blood sampling during period 1

throughout the first period you will attend scheduled clinic visits. at each visit a small amount of blood will be drawn to measure the amount of the contraceptive hormones in your bloodstream.

these blood samples help determine the baseline pharmacokinetic parameters, such as the total exposure (area under the curve) and the highest concentration reached after taking the tablet.

3 start of period 2 – add study drug bi 1358894

after completing the first period, you will begin the second period. during this time you will continue to take the same contraceptive tablet (ethinylestradiol 0.03 mg and drospirenone 3 mg) once daily.

in addition, you will receive a tablet of the study drug named bi 1358894 at a dose of 100 mg. this tablet is also taken by mouth once each day.

the study drug will be taken for multiple consecutive days as defined by the study protocol.

4 clinic visits and blood sampling during period 2

while you are taking both the contraceptive tablet and the study drug, you will again attend scheduled clinic visits.

at each visit additional blood samples will be collected to assess how the presence of bi 1358894 changes the amount of the contraceptive hormones in your blood.

the measurements will focus on the same pharmacokinetic parameters as in period 1, allowing a direct comparison.

5 completion of the study

after the final scheduled blood draw, you will stop taking the study medications.

the study staff will provide any remaining study information and will arrange a final safety check.

Who Can Join the Study?

Healthy premenopausal female – you must be a woman who has not yet gone through menopause and be judged healthy by the study doctor after a full medical history, physical and pelvic exam, checking blood pressure and pulse, a simple heart test (called a 12‑lead ECG), and laboratory tests.
Age between 18 and 35 years – you need to be at least 18 years old and not older than 35.
Body‑mass index (BMI) from 18.5 to 29.9 – this is a number that compares your weight to your height; you must fall within this range.
Signed written informed consent – you must read, sign, and date a consent form that explains the study and your rights before you begin.
Use of a highly effective birth‑control method from at least 30 days before the first dose until 30 days after the study ends. Acceptable methods include using a hormonal pill together with a barrier method (like condoms) and being willing to stop the pill while continuing the barrier method plus the study drug; having a non‑hormonal intrauterine device (IUD); being sexually abstinent; having had tubal ligation (a permanent surgical closure of the fallopian tubes); or having a partner who has had a successful vasectomy (surgical cutting of the sperm‑carrying tubes) and is your only sexual partner.

Who Cannot Join the Study?

Any abnormal result in the medical exam (such as blood pressure, pulse, or heart test) that the doctor thinks is important, for example large varicose veins, a clot in a vein called thrombophlebitis, or signs of poor blood flow in the arms or legs.
Having an active or suspected cancer, or a history of cancer within the past five years, except for a skin cancer called basal cell carcinoma that was properly treated.
Having a serious allergy or hypersensitivity, including an allergy to the study medication or any of its inactive ingredients.
Taking any medicines in the 30 days before the study that could affect the results, especially drugs that can lengthen the heart’s QT/QTc interval (a measurement of heart rhythm).
Repeated blood pressure readings that are too low or too high (systolic blood pressure not between 90‑140 mmHg, diastolic blood pressure not between 50‑90 mmHg) or a pulse rate outside 50‑90 beats per minute.
Any lab test result that is outside the normal range and the doctor considers important.
Any other disease that the doctor judges to be clinically relevant.
Major problems with the digestive system (gastrointestinal), liver (hepatic), kidneys (renal), lungs (respiratory), heart and blood vessels (cardiovascular), metabolism (metabolic), immune system (immunological), or hormones (hormonal disorders).
Having had the gallbladder removed (cholecystectomy) or other major stomach or intestine surgery that could change how the drug is absorbed, except for a simple appendix removal or hernia repair.
Diseases of the brain or spinal cord (central nervous system), such as seizures or stroke, and other serious neurological or psychiatric conditions.
History of significant drop in blood pressure when standing up (orthostatic hypotension), fainting spells, or blackouts.
Having a serious ongoing infection, whether long‑term (chronic) or sudden (acute).

Where you can join this trial?

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Site Name	City	Country	Status
Ctk Cqbjmmki Rpngwxno Skohpwar Munpjbvtfp Gmay	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	20.07.2023

Trial locations

Investigated Drugs:

BI 1358894 is an experimental oral medication being studied in tablet form. In this trial participants take the drug repeatedly to see how it may change the way the body processes other hormones.

Yasmin® is a combined oral contraceptive pill that contains the two hormones drospirenone and ethinylestradiol. The study uses this pill to evaluate how its hormone levels are affected when the experimental drug is taken at the same time.

Ethinylestradiol is a synthetic form of estrogen that is commonly included in birth‑control pills. In the trial it is examined on its own to understand how its absorption and elimination might be altered by the experimental medication.

Drospirenone is a synthetic progestin that works together with estrogen in many contraceptive pills. The study looks at how this hormone behaves in the body when participants are also receiving the investigational drug.

Trial ID:

2022-502861-78-00

Protocol code:

1402-0019

Trial Phase:

Human Pharmacology (Phase I) – Other

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Effect of multiple doses of BI 1358894 on the pharmacokinetics of ethinylestradiol and drospirenone in healthy women

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?