Status:
COMPLETED
First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784
Lead Sponsor:
Bayer
Conditions:
Clinical Trials, Phase I as Topic
Eligibility:
FEMALE
45-65 years
Phase:
PHASE1
Brief Summary
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 d...
Eligibility Criteria
Inclusion
- Healthy female subjects
- Age 45 to 65 years
- Body mass index (BMI) above/equal 20 and below/equal 30 kg/m2
- Postmenopausal state
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02212080
Start Date
September 1 2014
End Date
March 1 2015
Last Update
March 11 2015
Active Locations (2)
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1
Mönchengladbach, North Rhine-Westphalia, Germany, 41061
2
Erfurt, Thuringia, Germany, 99084