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

Phase 1

Completed

• Conditions: Endometriosis
• Interventions: Drug: BAY1128688; Drug: Placebo

• Registration Number: NCT02434640
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-30
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-05
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAY1128688 [Dose2]	BAY1128688	BAY1128688 dose level 2
BAY1128688 [Dose3]	BAY1128688	BAY1128688 dose level 3
Placebo	Placebo	Placebo to match arm 1,2, 3 and 4
BAY1128688 [Dose4]	BAY1128688	BAY1128688 dose level 4
BAY1128688 [Dose1]	BAY1128688	BAY1128688 dose level 1

Primary Outcome Measures

Name	Time	Method
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)