check_circleStudy Completed

Clinical Trials, Phase I as Topic

Bayer Identifier:

16924

ClinicalTrials.gov Identifier:

NCT02212080

EudraCT Number:

2014-000412-34

EU CT Number:

Not Available
First in human study in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of BAY1214784

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.

Key Participants Requirements

Sex

Female

Age

45 - 65 Years
  • - Healthy female subjects
    - Age 45 to 65 years
    - Body mass index (BMI) above/equal 20 and below/equal 30 kg/m2
    - Postmenopausal state
  • - 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
September 2014 - March 2015
Phase
Phase 1
Could I Receive a placebo
Yes
Products
BAY1214784
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Mönchengladbach GmbHMönchengladbach, 41061, Germany
Completed
SocraTec R&D Clinical WardErfurt, 99084, Germany

Primary Outcome

  • Number of adverse events
    date_rangeTime Frame:
    Up to 2 weeks after dosing
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    Safety Issue:
    Yes
  • Severity of adverse events (mild, moderate, severe)
    date_rangeTime Frame:
    Up to 2 weeks after dosing
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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