Study Completed

Endometriosis

Bayer Identifier:

16742

ClinicalTrials.gov Identifier:

NCT02434640

EudraCT Number:

2014-005298-36

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Female

Age

18 - 68 Years

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

Trial Dates

April 2015 - April 2016

Phase

Phase 1

Could I Receive a placebo

Yes

Products

BAY1128688

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	CRS Clinical Research Services Berlin GmbH	Berlin, 13353, Germany
Completed	Nuvisan GmbH	Neu-Ulm, 89231, Germany
Completed	PAREXEL GmbH	Berlin, 14050, Germany

Primary Outcome

Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading
Time Frame:
Up to 2 months
Safety Issue:
Yes
Cmax,md (maximum concentration) of BAY1128688 after multiple dose
Time Frame:
0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
Safety Issue:
No
Cav,md (average steady state concentration) of BAY1128688 after multiple dose
Time Frame:
0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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