A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Blood

Korábbi kezelés

• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Cholecystectomy, and/or prior surgery of the gastrointestinal (GI) tract (including bariatric surgery) or any relevant anatomical malformation of the GI tract that could interfere with the pharmacokinetics of the trial medication (investigational medicinal product (IMP) or auxiliary medicinal product (AxMP)) - except appendectomy or simple hernia repair

Más betegség

• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• History of either chronic or acute pancreatitis
• Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply

Laborértékek

• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and/or liver enzymes (alanine transaminase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT)) and/or pancreatic enzymes (amylase lipase) above upper limit of normal range +10% at screening examination, confirmed by a repeat test

Egyéb

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)

• Otherwise healthy women according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 60 years (inclusive)
• Body mass index (BMI) of 27.0 to 40.0 kg/m2 (inclusive)
• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial, i.e. prior to starting any screening procedures
• Subject fulfills any of the following criteria at least 4 weeks prior to allocation of subject number (i.e. prior to Day 1 of period 1):
  • Use of non-hormone releasing intrauterine device (IUD) and male partner must be vasectomised (provided that partner is the sole sexual partner of the trial participant) with documented absence of sperm or use a condom
  • Bilateral tubal ligation and male partner must be vasectomised (provided that partner is the sole sexual partner of the trial participant) with documented absence of sperm or use a condom
  • Sexually abstinent (i.e. subjects must abstain from male-female sex)
  • Surgically sterilised (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
  • Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)