Age and Gender Effects on the Pharmacokinetics of BAY85-3934

NCT ID: NCT01458028

Last Updated: 2014-05-06

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

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

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Single dose study of BAY85-3934 compared to placebo in young/elderly male and female healthy subjects. The main focus of the study is to determine if the pharmacokinetics (drug levels in blood) of BAY85-3934 is similar or not in the four subject groups. Qualifying subjects will be dosed with a single tablet of BAY85-3934 (or placebo) and blood will be drawn over 4 days. The safety and tolerability of BAY85-3934 compared to placebo will also be evaluated over the 5 days of the study.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

BAY85-3934

Intervention Type DRUG

Single doses of 20 mg BAY85-3934 as tablet

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet

Interventions

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BAY85-3934

Single doses of 20 mg BAY85-3934 as tablet

Intervention Type DRUG

Placebo

Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No diagnosis of any specific disease or condition
* Subjects are expected to be in good general health for their respective age range
* Male or female gender
* Age subgroups: 1) 18 to 45 years (inclusive) and 2) 65 to 85 years (inclusive)
* Racial group: Caucasian

Exclusion Criteria

* 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. This includes moderate and severe renal impairment (on dialysis or not), and moderate or severe hepatic disease.
* Clinically relevant findings in the physical examination
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

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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Fargo, North Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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14631

Identifier Type: -

Identifier Source: org_study_id

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