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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations CRS Clinical-Research-Services Mönchengladbach GmbH Mönchengladbach, Germany, 41061 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SocraTec R&D Clinical Ward Erfurt, Germany, 99084 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
One-center, randomized, placebo-controlled, double blind, parallel group study to investigate the safety, tolerability and pharmacokinetics of increasing single oral doses (5-1000 mg, solution) of BAY1214784 including the relative bioavailability of BAY1214784 administered as solution with two different concentrations in 56 healthy postmenopausal women
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Number of adverse eventsTimeframe: Up to 2 weeks after dosing
- Severity of adverse events (mild, moderate, severe)Timeframe: Up to 2 weeks after dosing
Additional Information
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