check_circleStudy 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
  • 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
  • - 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
April 2015 - April 2016
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY1128688
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical Research Services Berlin GmbHBerlin, 13353, Germany
Completed
Nuvisan GmbHNeu-Ulm, 89231, Germany
Completed
PAREXEL GmbHBerlin, 14050, Germany

Primary Outcome

  • Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading
    date_rangeTime Frame:
    Up to 2 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Cmax,md (maximum concentration) of BAY1128688 after multiple dose
    date_rangeTime Frame:
    0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
    enhanced_encryption
    Safety Issue:
    No
  • Cav,md (average steady state concentration) of BAY1128688 after multiple dose
    date_rangeTime Frame:
    0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
    enhanced_encryption
    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
5

Additional Information

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