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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: BAY1128688; Drug: BAY1128688; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
  • Berlin, Germany, 14050
  • Bayern
    • Neu-Ulm, Bayern, Germany, 89231

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

PART A

• Postmenopausal state, revealed by

  1. 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
  2. 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)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Estimate): May 19, 2016
• Last Update Submitted That Met QC Criteria: May 18, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 16742; 2014-005298-36 (EudraCT Number)