Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Drug: BAY1161116
* Drug: Placebo
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY1161116<br>Dose steps 1 to 6 of BAY1161116 (increasing dose levels) | Drug: BAY1161116<br>* Escalating doses of BAY1161116; single dose administration; redosing of BAY1161116 at dose group 1 together with itraconazole; redosing of BAY1161116 at dose group 2 as liquid service formulation, redosing of BAY1161116 at dose group 3 together with food<br>Drug: Itraconazole<br>* Redosing of BAY1161116/placebo at dose group 1 together with itraconazole<br>|
| Placebo Comparator: Placebo<br>Placebo Dose 1 to 6 of BAY 1161116 | Drug: Placebo<br>* Escalating doses of respective placebos; single dose administration; redosing of placebo at dose group 1 together with itraconazole; redosing of placebo at dose group 2 as liquid service formulation, redosing of placebo at dose group 3 together with food<br>Drug: Itraconazole<br>* Redosing of BAY1161116/placebo at dose group 1 together with itraconazole<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS