Terminated/Withdrawn

Polycystic ovary syndrome

Bayer Identifier:

18752

ClinicalTrials.gov Identifier:

NCT03119077

EudraCT Number:

2016-003520-23

EU CT Number:

Not Available

Single ascending dose, First-in-Human study on safety, tolerability and pharmacokinetics of BAY1161116

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.

Key Participants Requirements

Sex

Female

Age

45 - 65 Years

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

April 2017 - January 2018

Phase

Phase 1

Could I Receive a placebo

Yes

Products

BAY1161116

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Terminated	CRS Clinical Research Services Berlin GmbH	Berlin, 13353, Germany

Primary Outcome

Incidence of TEAEs
TEAEs: treatment-emergent adverse events
Time Frame:
5 weeks
Severity of TEAEs
TEAEs: treatment-emergent adverse events
Time Frame:
5 weeks
AUC of BAY1161116
AUC: Area under the concentration vs. time curve from zero to infinity
Time Frame:
5 weeks
Cmax of BAY1161116
Cmax: maximum observed drug concentration
Time Frame:
5 weeks

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

Additional Information

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