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:

NCT03119077

EudraCT Number:

2016-003520-23

Terminated/Withdrawn

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
32
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
BAY1161116
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical Research Services Berlin GmbH

Berlin, Germany, 13353

Status
Terminated
 

Trial Design