Trial Condition(s):

Clinical Trials, Phase I as Topic

First in human study in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of BAY1214784

Bayer Identifier:

16924

ClinicalTrials.gov Identifier:

NCT02212080

EudraCT Number:

2014-000412-34

Study Completed

Trial Purpose

This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled, randomized, single center design. In addition the bioavailability of two different liquid formulations will be compared.

Inclusion Criteria
- Healthy female subjects
 - Age 45 to 65 years 
 - Body mass index (BMI) above/equal 20 and below/equal 30 kg/m2
 - Postmenopausal state
Exclusion Criteria
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
 - Known or suspected malignant or benign tumors
 - Known or suspected liver disorders, relevant kidney diseases, known cardiovascular diseases, known metabolic disorders
 - Regular use of medicines

Trial Summary

Enrollment Goal
48
Trial Dates
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Phase
1
Could I receive a placebo?
Yes
Products
BAY1214784
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical-Research-Services Mönchengladbach GmbH

Mönchengladbach, Germany, 41061

Status
Completed
 
Locations

SocraTec R&D Clinical Ward

Erfurt, Germany, 99084

Status
Completed
 

Trial Design