Trial Condition(s):
Polycystic ovary syndrome
Single ascending dose, First-in-Human study on safety, tolerability and pharmacokinetics of BAY1161116
Bayer Identifier:
18752
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations CRS Clinical Research Services Berlin GmbH Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Randomized, double-blind, placebo-controlled, escalating single dose study of the safety, tolerability, and pharmacokinetics of orally administered BAY1161116 in healthy postmenopausal women including food-effect and drug-drug-interaction with itraconazole
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Incidence of TEAEsTEAEs: treatment-emergent adverse eventsTimeframe: 5 weeks
- Severity of TEAEsTEAEs: treatment-emergent adverse eventsTimeframe: 5 weeks
- AUC of BAY1161116AUC: Area under the concentration vs. time curve from zero to infinityTimeframe: 5 weeks
- Cmax of BAY1161116Cmax: maximum observed drug concentrationTimeframe: 5 weeks
Additional Information
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