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

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ClinicalTrials.gov Identifier: NCT02434640
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: BAY1128688 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women
Study Start Date : April 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: BAY1128688 [Dose1]
BAY1128688 dose level 1
Drug: BAY1128688
Part A: Single dose and multiple dose for 14 days (postmenopausal 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)

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)




Primary Outcome Measures :
  1. Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading [ Time Frame: Up to 2 months ]
  2. 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) ]
  3. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434640


Locations
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Germany
Neu-Ulm, Bayern, Germany, 89231
Berlin, Germany, 13353
Berlin, Germany, 14050
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02434640    
Other Study ID Numbers: 16742
2014-005298-36 ( EudraCT Number )
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female