Clinical trial NCT02434640: Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women
Official title: Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endometriosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-05-05
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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)

Primary outcomes:
measure: Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading
timeFrame: Up to 2 months
measure: Cmax,md (maximum concentration) of BAY1128688 after multiple dose
timeFrame: 0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
measure: Cav,md (average steady state concentration) of BAY1128688 after multiple dose
timeFrame: 0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
Secondary outcomes:
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
state: Bayern
city: Berlin
country: Germany
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: