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Clinical Trials/NCT02170831
NCT02170831CompletedPhase 1

Safety, Pharmacodynamics, and Pharmacokinetics After Multiple Oral Doses of 50, 100, 200, and 400 mg BIBR 1048 MS Solution Administered TID for 7 Days to Healthy Volunteer Subjects. An Open Study, Placebo-controlled Randomised Double Blind at Each Dose Level

Boehringer Ingelheim0 sites40 target enrollmentStarted: May 1999Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
40
Primary Endpoint
Change in aPTT (activated partial thromboplastin time)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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%

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

Arms & Interventions

BIBR 1048 MS low dose

Experimental

Intervention: BIBR 1048 MS low (Drug)

BIBR 1048 MS medium dose 1

Experimental

Intervention: BIBR 1048 MS medium 1 (Drug)

BIBR 1048 MS medium dose 2

Experimental

Intervention: BIBR 1048 MS medium 2 (Drug)

BIBR 1048 MS high dose

Experimental

Intervention: BIBR 1048 MS high (Drug)

BIBR 1048 Placebo

Placebo Comparator

Intervention: BIBR 1048 MS placebo (Drug)

Outcomes

Primary Outcomes

Change in aPTT (activated partial thromboplastin time)

Time Frame: up to day 10

Change in PT (prothrombin time)

Time Frame: up to day 10

Secondary Outcomes

  • tmax,ss (time to reach Cmax) of BIBR 953 ZW(up to day 10)
  • Cmax (maximum measured concentration) of BIBR 953 ZW(up to day 10)
  • Cavg (average plasma concentration at steady state) 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)
  • Cmin,ss (minimum measured concentration at steady state) of BIBR 953 ZW(Day 7)
  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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