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

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)