Multiple Oral Doses of BIBR 1048 MS Solution in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BIBR 1048 MS low; Drug: BIBR 1048 MS medium 1; Drug: BIBR 1048 MS medium 2; Drug: BIBR 1048 MS high; Drug: BIBR 1048 MS placebo

• Registration Number: NCT02170831
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-05
• Primary Completion: 1999-07
• Status Verified: 2014-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-20
• Last Update Submitted: 2014-06-20
• Study First Posted: 2014-06-23
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• 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%

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Exclusion Criteria

• 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

• Alcohol abuse (> 60 g/day)

• Drug abuse

• Blood donation within 1 month prior to administration or during the trial

• Excessive physical activities within 5 days prior to administration or during the trial

• Any laboratory value outside the clinically accepted reference range

• History of any familial bleeding disorder

• Thrombocytes < 150000/µl

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIBR 1048 MS low dose	BIBR 1048 MS low	-
BIBR 1048 MS medium dose 1	BIBR 1048 MS medium 1	-
BIBR 1048 MS medium dose 2	BIBR 1048 MS medium 2	-
BIBR 1048 MS high dose	BIBR 1048 MS high	-
BIBR 1048 Placebo	BIBR 1048 MS placebo	-

Primary Outcome Measures

Name	Time	Method
Change in aPTT (activated partial thromboplastin time)	up to day 10
Change in PT (prothrombin time)	up to day 10

Secondary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration) of BIBR 953 ZW	up to day 10
Cmin,ss (minimum measured concentration at steady state) of BIBR 953 ZW	Day 7
Cavg (average plasma concentration at steady state) of BIBR 953 ZW	up to day 10
tmax,ss (time to reach Cmax) 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
t1/2 (terminal half-life) of BIBR 953 ZW	up to day 10
Cmax,ss (maximum measured concentration at steady state) of BIBR 953 ZW	Day 7
PTF (percent peak trough fluctuation for the last dosing interval) of BIBR 953 ZW	up to day 10
AUCss (area under the plasma concentration-time curve of one dosing interval at steady state) of BIBR 953 ZW	up to day 10
CLtot/F (total apparent clearance) of BIBR 953 ZW	up to day 10
MRTss (mean residence time at steady state) of BIBR 953 ZW	up to day 10
Vz/F (apparent volume of distribution) of BIBR 953 ZW	up to day 10