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CompletedNCT02170740Updated Jun 23, 2014

Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer Subjects

A Phase 1 interventional study of BIBR 1048 MS - low dose and BIBR 1048 MS - high dose in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 18 Years to 50 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
26
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

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

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 50 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 ≤ 50 years
  • Broca ≥ - 20% and ≤ + 20%

Exclusion criteria

Exclusion Criteria:

  • Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (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
  • History of any bleeding disorder including prolonged or habitual bleeding
  • History of other hematologic disease
  • History of cerebral bleeding (e.g. after a car accident)
  • History of commotio cerebri
  • Intake of drugs with a long-life (> 24 hours) within 1 month prior to administration
  • Use of any drug which might influence the results of the trial within 10 days prior to administration or during the trial
  • Participation in another trial with investigational drug within 2 months prior to administration or during the trial
  • Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
  • Alcohol abuse (> 60g/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 familiar bleeding disorder
  • Thrombocytes \< 150000/µl
05

Study design

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

Study arms

  • Experimental
    BIBR 1048 MS

    Drug: BIBR 1048 MS - low dose · Drug: BIBR 1048 MS - high dose

  • Experimental
    BIBR 1048 MS + Pantoprazole

    Drug: BIBR 1048 MS - high dose · Drug: BIBR 1048 MS + Pantoprazole

Interventions

  • DrugBIBR 1048 MS - low dose
  • DrugBIBR 1048 MS - high dose
  • DrugBIBR 1048 MS + Pantoprazole
06

What researchers measure

Primary outcomes

  1. Urinary excretion of total BIBR 953 ZW

    Time frame: Day 1, day 2, day 3 (different time points)

  2. Peak (maximum) plasma concentration at steady state (Cmax,ss) of BIBR 953 ZW

    Time frame: Day 1, day 2, day 3 (different time points)

  3. Area under the plasma concentration-time curve at steady state (AUCss) of BIBR 953 ZW

    Time frame: Day 1, day 2, day 3 (different time points)

  4. Amount of total (free and glucuronide) BIBR 953 ZW excreted in urine over one dosing interval

    Time frame: Day 1, day 2, day 3 (different time points)

Secondary outcomes

  1. Time to reach the peak plasma concentration (Tmax,ss) of BIBR 953ZW

    Time frame: Day 1, day 2, day 3 (different time points)

  2. Total clearance (CLtot /f ) of BIBR 953 ZW after oral administration

    Time frame: Day 1, day 2, day 3 (different time points)

  3. Occurence of adverse events

    Time frame: 6 weeks

  4. Change from Baseline in pulse rate

    Time frame: Baseline, day 1,day 2, day 3, day 4

  5. Change from Baseline in systolic and diastolic blood pressure

    Time frame: Baseline, day 1,day 2, day 3, day 4

  6. Change from Baseline in clinical laboratory tests

    Time frame: Baseline, day 1,day 2, day 3, day 4

  7. Changes from baseline in activated partial thromboplastin time (aPTT)

    Time frame: Day 1, day 2, day 3 (different time points)

  8. Changes from baseline in prothrombin time (PT) (International Normalised Ratio (INR))

    Time frame: Day 1, day 2, day 3 (different time points)

  9. Total mean residence time (MRTtot) of BIBR 953 ZW after oral administration

    Time frame: ay 1, day 2, day 3 (different time points)

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
NCT02170740
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jun 23, 2014
Start date
Nov 1999
Primary completion
Jan 2000
Last update
Jun 23, 2014
View the source record on ClinicalTrials.gov ↗

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