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

NCT02434640 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2016-05-19

No results posted yet for this study

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

Interventions

DRUG

BAY1128688

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

DRUG

Placebo

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

DRUG

BAY1128688

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
68 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-12-31
Completion
2016-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02434640 on ClinicalTrials.gov