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

NCT ID: NCT02212080

Last Updated: 2015-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Clinical Trials, Phase I as Topic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BAY1214784

Dose 1 to 7 of BAY1214784

Group Type EXPERIMENTAL

BAY1214784

Intervention Type DRUG

Escalating doses of 5, 20, 60, 150, 300, 600, 1000 mg of BAY1214784; single dose administration; liquid dosage form

Placebo

Placebo Dose 1 to 7 of BAY1214784

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose 1, 2,3, 4, 5, 6 and 7 of respective placebos; single dose administration; liquid dosage form

Interventions

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BAY1214784

Escalating doses of 5, 20, 60, 150, 300, 600, 1000 mg of BAY1214784; single dose administration; liquid dosage form

Intervention Type DRUG

Placebo

Dose 1, 2,3, 4, 5, 6 and 7 of respective placebos; single dose administration; liquid dosage form

Intervention Type DRUG

Eligibility 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Mönchengladbach, North Rhine-Westphalia, Germany

Site Status

Erfurt, Thuringia, Germany

Site Status

Countries

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Germany

Other Identifiers

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2014-000412-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16924

Identifier Type: -

Identifier Source: org_study_id

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