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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Hemorrhage

Treatments: Drug: Placebo; Drug: BI 655075

Study type: Interventional

Funder types: Industry

Identifiers

NCT01955720

1321.2

2013-003616-52 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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46 participants in 4 patient groups

healthy subjects aged 45-64

Experimental group

Description:

Sequential Crossover to Placebo or BI 655075

Treatment:

Drug: Placebo

Drug: BI 655075

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: BI 655075

Drug: BI 655075

Drug: BI 655075

healthy elderly subjects aged 65-80 year

Experimental group

Description:

Sequential Crossover to Placebo or BI 655075

Treatment:

Drug: Placebo

Drug: BI 655075

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: BI 655075

Drug: BI 655075

Drug: BI 655075

mild renal impairment aged 45-80 years

Experimental group

Description:

Sequential Crossover to Placebo or BI 655075

Treatment:

Drug: Placebo

Drug: BI 655075

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: BI 655075

Drug: BI 655075

Drug: BI 655075

mod renal impairment aged 45-80 years

Experimental group

Description:

Sequential Crossover to Placebo or BI 655075

Treatment:

Drug: Placebo

Drug: BI 655075

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: BI 655075

Drug: BI 655075

Drug: BI 655075