Trial Condition(s):

Endometriosis

Ascending dose study to investigate the safety, tolerability and pharmacokinetics of BAY1128688 after multiple oral administrations in healthy women

Bayer Identifier:

16742

ClinicalTrials.gov Identifier:

NCT02434640

EudraCT Number:

2014-005298-36

Study Completed

Trial Purpose

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.

Inclusion Criteria
PART A
 - Postmenopausal state, revealed by 
a) 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 
b) 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)

Trial Summary

Enrollment Goal
51
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
BAY1128688
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical Research Services Berlin GmbH

Berlin, Germany, 13353

Status
Completed
 
Locations

Nuvisan GmbH

Neu-Ulm, Germany, 89231

Status
Completed
 
Locations

PAREXEL GmbH

Berlin, Germany, 14050

Status
Completed
 

Trial Design