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

NCT ID: NCT02434640

Last Updated: 2016-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-04-30

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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

BAY1128688 [Dose1]

BAY1128688 dose level 1

Group Type: EXPERIMENTAL

BAY1128688

Intervention Type: DRUG

Part A: Single dose and multiple dose for 14 days (postmenopausal women)

BAY1128688 [Dose2]

BAY1128688 dose level 2

Group Type: EXPERIMENTAL

BAY1128688

Intervention Type: DRUG

Part A: Single dose and multiple dose for 14 days (postmenopausal women)

BAY1128688

Intervention Type: DRUG

Part B: Multiple dose for 28 days (premenopausal women)

BAY1128688 [Dose3]

BAY1128688 dose level 3

Group Type: EXPERIMENTAL

BAY1128688

Intervention Type: DRUG

Part A: Single dose and multiple dose for 14 days (postmenopausal women)

BAY1128688

Intervention Type: DRUG

Part B: Multiple dose for 28 days (premenopausal women)

BAY1128688 [Dose4]

BAY1128688 dose level 4

Group Type: EXPERIMENTAL

BAY1128688

Intervention Type: DRUG

Part A: Single dose and multiple dose for 14 days (postmenopausal women)

Placebo

Placebo to match arm 1,2, 3 and 4

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Part A: Single dose and multiple dose for 14 days (postmenopausal women)

Interventions

BAY1128688

Part A: Single dose and multiple dose for 14 days (postmenopausal women)

Intervention Type: DRUG

Placebo

Part A: Single dose and multiple dose for 14 days (postmenopausal women)

Intervention Type: DRUG

BAY1128688

Part B: Multiple dose for 28 days (premenopausal women)

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Neu-Ulm, Bavaria, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Countries

Germany

References

Gashaw I, Reif S, Wiesinger H, Kaiser A, Zollmann FS, Scheerans C, Grevel J, Piraino P, Seidel H, Peters M, Rottmann A, Rohde B, Arlt W, Hilpert J. Novel aldo-keto reductase 1C3 inhibitor affects androgen metabolism but not ovarian function in healthy women: a phase 1 study. Eur J Endocrinol. 2023 Jul 10;188(7):578-591. doi: 10.1093/ejendo/lvad063.

Reference Type: DERIVED

PMID: 37306288 (View on PubMed)

Other Identifiers

2014-005298-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16742

Identifier Type: -

Identifier Source: org_study_id