Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women

Study Overview
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Brief Summary
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The objective of this trial is to investigate the safety and tolerability of BAY1128688 and to determine the concentration of this substance in blood after repeated administration by the oral route. The investigational substance will be administered in tablet form to healthy women.

Official Title
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Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: BAY1128688
* Drug: Placebo
* Drug: BAY1128688


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PART A Postmenopausal state, revealed by Medical history. One of the following: Natural menopause at least 12 months prior to first study drug administration, Surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administration) or Hysterectomy AND Follicle-stimulating hormone (FSH) > 40 IU/L Age 45 to 68 years PART B Healthy female subjects Sterilized by tubal-ligation Pre-treatment menstrual cycle assessed as ovulatory Completion of more than 3 menstrual cycles after delivery, abortion or lactation Age 18 to 48 years Exclusion Criteria: Body mass index (kg/m2) greater or equal 32 (or less or equal 18) Smoking: PART A: non-smoking; PART B: less than 10 cigarettes per day Use of medicines including but not restricted to contraceptives and NSAIDs (details regarding previous use of medicines provided by the study center) Ability and willingness to adhere to restrictions regarding diet (PART A and B) and to eat standardised meals (PART A only) Significant diseases of the heart, gastrointestinal tract and/or liver and/or kidney and/or reproductive organs (present or in the past; details will be provided by the study center) Recent infectious diseases (details will be provided by the study center) Migraine or depression Thyroid disease which requires treatment Metabolic disorders, for example diabetes mellitus or hypertriglyceridemia Drug or alcohol abuse; regular consumption of more than 800 ml of beer per day (or other drinks resembling 40 g of alcohol)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY1128688 [Dose1]<br>BAY1128688 dose level 1 | Drug: BAY1128688<br>* Part A: Single dose and multiple dose for 14 days (postmenopausal women)<br>|
| Experimental: BAY1128688 [Dose2]<br>BAY1128688 dose level 2 | Drug: BAY1128688<br>* Part A: Single dose and multiple dose for 14 days (postmenopausal women)<br>Drug: BAY1128688<br>* Part B: Multiple dose for 28 days (premenopausal women)<br>|
| Experimental: BAY1128688 [Dose3]<br>BAY1128688 dose level 3 | Drug: BAY1128688<br>* Part A: Single dose and multiple dose for 14 days (postmenopausal women)<br>Drug: BAY1128688<br>* Part B: Multiple dose for 28 days (premenopausal women)<br>|
| Experimental: BAY1128688 [Dose4]<br>BAY1128688 dose level 4 | Drug: BAY1128688<br>* Part A: Single dose and multiple dose for 14 days (postmenopausal women)<br>|
| Placebo Comparator: Placebo<br>Placebo to match arm 1,2, 3 and 4 | Drug: Placebo<br>* Part A: Single dose and multiple dose for 14 days (postmenopausal women)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading |  | Up to 2 months | 
| Cmax,md (maximum concentration) of BAY1128688 after multiple dose |  | 0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only) | 
| Cav,md (average steady state concentration) of BAY1128688 after multiple dose |  | 0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only) |