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CompletedNCT02170831Updated Jun 23, 2014

Multiple Oral Doses of BIBR 1048 MS Solution in Healthy Volunteers

A Phase 1 interventional study of BIBR 1048 MS low and BIBR 1048 MS medium 1 in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-23.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    BIBR 1048 MS low dose

    Drug: BIBR 1048 MS low

  • Experimental
    BIBR 1048 MS medium dose 1

    Drug: BIBR 1048 MS medium 1

  • Experimental
    BIBR 1048 MS medium dose 2

    Drug: BIBR 1048 MS medium 2

  • Experimental
    BIBR 1048 MS high dose

    Drug: BIBR 1048 MS high

  • Placebo comparator
    BIBR 1048 Placebo

    Drug: BIBR 1048 MS placebo

Interventions

  • DrugBIBR 1048 MS low
  • DrugBIBR 1048 MS medium 1
  • DrugBIBR 1048 MS medium 2
  • DrugBIBR 1048 MS high
  • DrugBIBR 1048 MS placebo
06

What researchers measure

Primary outcomes

  1. Change in aPTT (activated partial thromboplastin time)

    Time frame: up to day 10

  2. Change in PT (prothrombin time)

    Time frame: up to day 10

Secondary outcomes

  1. Cmax (maximum measured concentration) of BIBR 953 ZW

    Time frame: up to day 10

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

    Time frame: up to day 10

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

    Time frame: up to day 10

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

    Time frame: Day 7

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

    Time frame: Day 7

  6. Cavg (average plasma concentration at steady state) of BIBR 953 ZW

    Time frame: up to day 10

  7. PTF (percent peak trough fluctuation for the last dosing interval) of BIBR 953 ZW

    Time frame: up to day 10

  8. tmax,ss (time to reach Cmax) of BIBR 953 ZW

    Time frame: up to day 10

  9. t1/2 (terminal half-life) of BIBR 953 ZW

    Time frame: up to day 10

  10. AUCss (area under the plasma concentration-time curve of one dosing interval at steady state) of BIBR 953 ZW

    Time frame: up to day 10

  11. MRTss (mean residence time at steady state) of BIBR 953 ZW

    Time frame: up to day 10

  12. CLtot/F (total apparent clearance) of BIBR 953 ZW

    Time frame: up to day 10

  13. Vz/F (apparent volume of distribution) of BIBR 953 ZW

    Time frame: up to day 10

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02170831
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jun 23, 2014
Start date
May 1999
Primary completion
Jul 1999
Last update
Jun 23, 2014
View the source record on ClinicalTrials.gov ↗

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