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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 March 2015 |
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Main ID: |
NCT02212080 |
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Date of registration:
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07/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784
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Scientific title:
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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 |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02212080 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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Phase:
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Phase 1
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Countries of recruitment
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Germany
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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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
Age minimum:
45 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Clinical Trials, Phase I as Topic
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Intervention(s)
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Drug: Placebo
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Drug: BAY1214784
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Primary Outcome(s)
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Severity of adverse events (mild, moderate, severe)
[Time Frame: Up to 2 weeks after dosing]
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Number of adverse events
[Time Frame: Up to 2 weeks after dosing]
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Secondary ID(s)
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2014-000412-34
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16924
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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