Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116
Phase 1
Terminated
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Registration Number
- NCT03119077
- Lead Sponsor
- Bayer
- Brief Summary
This study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of BAY1161116.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 32
Inclusion Criteria
- Healthy female postmenopausal subjects
- Age: 45 to 65 years (inclusive)
- Body mass index (BMI) : ≥18 and ≤30 kg/m²
- Non-smoker for 3 months (former smokers who quit smoking >3 months before the first study drug administration may be included)
Exclusion Criteria
- Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion,and effect of the study drugs will not be normal
- Any use of systemic or topically active medication or herbal remedies, prescription or non-prescription, from screening to the first drug administration (occasional use of paracetamol or ibuprofen is permissible)
- Any severe disease within the last 4 weeks prior to the first study drug administration
- History of orthostatic hypotension, fainting spells, blackouts
- Any malignant tumor and history thereof
- Any other medical condition which, at the discretion of the investigator, would make study participation unadvisable
- Any clinically relevant finding at the physical- and gynecological examinations
- Allergy, hypersensitivity, or non-allergic drug reactions to any excipient of the IMP or reference/interaction product
- Regular alcohol consumption equivalent to >20 g alcohol per day
- Urine screen positive for any drug or cotinine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BAY1161116 BAY1161116 Dose steps 1 to 6 of BAY1161116 (increasing dose levels) Placebo Placebo Placebo Dose 1 to 6 of BAY 1161116 Placebo Itraconazole Placebo Dose 1 to 6 of BAY 1161116 BAY1161116 Itraconazole Dose steps 1 to 6 of BAY1161116 (increasing dose levels)
- Primary Outcome Measures
Name Time Method Incidence of TEAEs 5 weeks TEAEs: treatment-emergent adverse events
Severity of TEAEs 5 weeks TEAEs: treatment-emergent adverse events
AUC of BAY1161116 5 weeks AUC: Area under the concentration vs. time curve from zero to infinity
Cmax of BAY1161116 5 weeks Cmax: maximum observed drug concentration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CRS Clinical Research Services Berlin GmbH
🇩🇪Berlin, Germany