Trial record 2 of 4 for:    BI 655075

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01955720
First received: September 30, 2013
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Hemorrhage
Drug: BI 655075
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled, Two-way Cross-over Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655075 and to Establish the Efficacy of BI 655075 in Reversal of Dabigatran Anticoagulant Activity in Volunteers

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Reversal of prolongation of blood coagulation time by dabigatran [ Time Frame: 10 minutes after completion of last infusion of BI 655075 ] [ Designated as safety issue: Yes ]
  • The endpoint for safety is the number (%) of subjects with BI 655075 related adverse events [ Time Frame: up to the 7 days pos dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 3 days post dose ] [ Designated as safety issue: No ]
  • Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 3 days post dose ] [ Designated as safety issue: No ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 1 hour post dose ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: September 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: healthy subjects aged 45-64
Sequential Crossover to Placebo or BI 655075
Drug: BI 655075 Drug: Placebo
Experimental: healthy elderly subjects aged 65-80 year
Sequential Crossover to Placebo or BI 655075
Drug: BI 655075 Drug: Placebo
Experimental: mild renal impairment aged 45-80 years
Sequential Crossover to Placebo or BI 655075
Drug: BI 655075 Drug: Placebo
Experimental: mod renal impairment aged 45-80 years
Sequential Crossover to Placebo or BI 655075
Drug: Placebo Drug: BI 655075

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955720

Locations
Belgium
1321.2.1 Boehringer Ingelheim Investigational Site
Antwerpen, Belgium
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01955720     History of Changes
Other Study ID Numbers: 1321.2, 2013-003616-52
Study First Received: September 30, 2013
Last Updated: August 13, 2014
Health Authority: Belgium: Federal Agency for Medicinal and Health Products

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014