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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434640
• Other study ID #: 16742
• Secondary ID: 2014-005298-36
• Status: Completed
• Phase: Phase 1
• First received: April 30, 2015
• Last updated: May 18, 2016
• Start date: April 2015
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 68 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• BAY1128688
Part A: Single dose and multiple dose for 14 days (postmenopausal women)
• Placebo
Part A: Single dose and multiple dose for 14 days (postmenopausal women)
• BAY1128688
Part B: Multiple dose for 28 days (premenopausal women)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading		Up to 2 months	Yes
Primary	Cmax,md (maximum concentration) of BAY1128688 after multiple dose		0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)	No
Primary	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)	No

External Links

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