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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-27

Study Completion Date

2018-01-31

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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BAY1161116

Dose steps 1 to 6 of BAY1161116 (increasing dose levels)

Group Type EXPERIMENTAL

BAY1161116

Intervention Type DRUG

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

Itraconazole

Intervention Type DRUG

Redosing of BAY1161116/placebo at dose group 1 together with itraconazole

Placebo

Placebo Dose 1 to 6 of BAY 1161116

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Itraconazole

Intervention Type DRUG

Redosing of BAY1161116/placebo at dose group 1 together with itraconazole

Interventions

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BAY1161116

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Itraconazole

Redosing of BAY1161116/placebo at dose group 1 together with itraconazole

Intervention Type DRUG

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes