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

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT02434640
Collaborator
(none)
51
Enrollment
3
Locations
5
Arms
12
Duration (Months)
17
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Apr 1, 2015
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading [Up to 2 months]

  2. Cmax,md (maximum concentration) of BAY1128688 after multiple dose [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 [0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 68 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

  1. 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neu-Ulm Bayern Germany 89231
2 Berlin Germany 13353
3 Berlin Germany 14050

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT02434640
Other Study ID Numbers:
  • 16742
  • 2014-005298-36
First Posted:
May 5, 2015
Last Update Posted:
May 19, 2016
Last Verified:
May 1, 2016
Additional relevant MeSH terms:
Endometriosis

Study Results

No Results Posted as of May 19, 2016