Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

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To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075 dose(s) effective to reverse prolongation of blood coagulation time by dabigatran

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Detailed Description

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Conditions

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Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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healthy subjects aged 45-64

Sequential Crossover to Placebo or BI 655075

Group Type EXPERIMENTAL

BI 655075

Intervention Type DRUG

Placebo

Intervention Type DRUG

healthy elderly subjects aged 65-80 year

Sequential Crossover to Placebo or BI 655075

Group Type EXPERIMENTAL

BI 655075

Intervention Type DRUG

Placebo

Intervention Type DRUG

mild renal impairment aged 45-80 years

Sequential Crossover to Placebo or BI 655075

Group Type EXPERIMENTAL

BI 655075

Intervention Type DRUG

Placebo

Intervention Type DRUG

mod renal impairment aged 45-80 years

Sequential Crossover to Placebo or BI 655075

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

BI 655075

Intervention Type DRUG

Interventions

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BI 655075

Intervention Type DRUG

BI 655075

Intervention Type DRUG

Placebo

Intervention Type DRUG

BI 655075

Intervention Type DRUG

Placebo

Intervention Type DRUG

Placebo

Intervention Type DRUG

Placebo

Intervention Type DRUG

BI 655075

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy midage male and female volunteers, age =45 and =64 years, BMI range: =18.5 and =29.9 kg/m2
* Healthy elderly male and female volunteers, age =65 and =80 years, BMI range: =18.5 and = 32 kg/m2
* Male and female volunteers with mild renal impairment (CLcrd 60-90 (mL/min)) in relatively good health, age =45 and =80 years, BMI range: =18.5 and =32 kg/m2 Moderate renal impaired (CLcrd =30 to \<60 mL/min according Cockcroft\&Gault formula in relatively good health, age =45 and =80 years, BMI range: =18.5 and =32 kg/m2

Exclusion Criteria

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease (other than mild renal impairment in the respective group) A significant disease is defined as a disease which in the opinion of the investigator
* put the volunteer at risk because of participation in the study
* may influence the results of the study
* may influence the volunteer¿s ability to participate in the study
* is not in a stable condition Diabetic, hypercholesterolemia or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts.
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes