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First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784

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ClinicalTrials.gov Identifier: NCT02212080
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

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 design. In addition the bioavailability of two different liquid formulations will be compared.

Condition or disease Intervention/treatment Phase
Clinical Trials, Phase I as Topic Drug: BAY1214784 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : September 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: BAY1214784
Dose 1 to 7 of BAY1214784
Drug: BAY1214784
Escalating doses of 5, 20, 60, 150, 300, 600, 1000 mg of BAY1214784; single dose administration; liquid dosage form

Placebo Comparator: Placebo
Placebo Dose 1 to 7 of BAY1214784
Drug: Placebo
Dose 1, 2,3, 4, 5, 6 and 7 of respective placebos; single dose administration; liquid dosage form




Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: Up to 2 weeks after dosing ]
  2. Severity of adverse events (mild, moderate, severe) [ Time Frame: Up to 2 weeks after dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212080


Locations
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Germany
Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
Erfurt, Thüringen, Germany, 99084
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02212080     History of Changes
Other Study ID Numbers: 16924
2014-000412-34 ( EudraCT Number )
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015