NCT02434640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

8 months

First QC Date

April 30, 2015

Last Update Submit

May 18, 2016

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (3)

  • Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading

    Up to 2 months

  • Cmax,md (maximum concentration) of BAY1128688 after multiple dose

    0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)

  • 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)

Study Arms (5)

BAY1128688 [Dose1]

EXPERIMENTAL

BAY1128688 dose level 1

Drug: BAY1128688

BAY1128688 [Dose2]

EXPERIMENTAL

BAY1128688 dose level 2

Drug: BAY1128688

BAY1128688 [Dose3]

EXPERIMENTAL

BAY1128688 dose level 3

Drug: BAY1128688

BAY1128688 [Dose4]

EXPERIMENTAL

BAY1128688 dose level 4

Drug: BAY1128688

Placebo

PLACEBO COMPARATOR

Placebo to match arm 1,2, 3 and 4

Drug: Placebo

Interventions

BAY1128688DRUG

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

BAY1128688 [Dose1]BAY1128688 [Dose2]BAY1128688 [Dose3]BAY1128688 [Dose4]
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 68 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PART A
  • Postmenopausal state, revealed by
  • 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
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Neu-Ulm, Bavaria, 89231, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13353, Germany

Location

Unknown Facility

Berlin, State of Berlin, 14050, Germany

Location

Related Publications (1)

  • 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.

    PMID: 37306288DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

BAY1128688

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 5, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

April 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations

DE(3)