Multiple Oral Doses of BIBR 1048 MS Solution in Healthy Volunteers

NCT02170831 | Completed Phase 1

• 1 other identifier: 1160.2
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Change in aPTT (activated partial thromboplastin time)

  up to day 10

• Change in PT (prothrombin time)

  up to day 10

Secondary Outcomes (13)

• Cmax (maximum measured concentration) of BIBR 953 ZW

  up to day 10

• tmax (time from dosing to the maximum concentration) of BIBR 953 ZW

  up to day 10

• AUC0-∞ (area under the concentration-time curve the time interval from 0 extrapolated to infinity) of BIBR 953 ZW

  up to day 10

• Cmax,ss (maximum measured concentration at steady state) of BIBR 953 ZW

  Day 7

• Cmin,ss (minimum measured concentration at steady state) of BIBR 953 ZW

  Day 7

Study Arms (5)

BIBR 1048 MS low dose

EXPERIMENTAL

Drug: BIBR 1048 MS low

BIBR 1048 MS medium dose 1

EXPERIMENTAL

Drug: BIBR 1048 MS medium 1

BIBR 1048 MS medium dose 2

EXPERIMENTAL

Drug: BIBR 1048 MS medium 2

BIBR 1048 MS high dose

EXPERIMENTAL

Drug: BIBR 1048 MS high

BIBR 1048 Placebo

PLACEBO COMPARATOR

Drug: BIBR 1048 MS placebo

Interventions

BIBR 1048 MS low DRUG

BIBR 1048 MS low dose

BIBR 1048 MS medium 1 DRUG

BIBR 1048 MS medium dose 1

BIBR 1048 MS medium 2 DRUG

BIBR 1048 MS medium dose 2

BIBR 1048 MS high DRUG

BIBR 1048 MS high dose

BIBR 1048 MS placebo DRUG

BIBR 1048 Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects as determined by results of screening
• Signed written informed consent in accordance with GCP and local legislation
• Age ≥ 18 and ≤ 45 years
• Broca ≥ -20% and ≤ +20%

You may not qualify if:

• Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
• History of orthostatic hypotension, fainting spells and blackouts
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
• Chronic or relevant acute infections
• History of
• allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• any bleeding disorder including prolonged or habitual bleeding
• other hematologic disease
• cerebral bleeding (e.g. after a car accident)
• commotio cerebri
• Intake of drugs with a long half-life (\>24 hours) within 1 month prior to administration
• Use of any drugs which might influence the results of the trial within 10 days prior to administration or during trial
• Participation in another trial with an investigational drug within 2 months prior to administration or during trial
• Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: May 1, 1999
• Primary Completion: July 1, 1999
• Last Updated: June 23, 2014

Record last verified: 2014-06