Skip to main content
OpenTrials
Completed

NCT Number: NCT02254083

Tolerability and Pharmacokinetics/-Dynamics of BIBT 986 BS in Healthy Male Subjects

Study to assess the tolerability of an intravenous infusion of 0.5 and 1.0 mg (actual 0.8 mg) BIBT 986 BS per hour over 32 hours as well as pharmacokinetics and the effect on blood coagulation parameters

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subjects as determined by results of screening
  • Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
  • Age >= 18 and <= 55 years
  • BMI >= 18.5 and <= 29.9 kg/m2

Exclusion criteria

  • Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
  • Surgery of gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • Relevant history of orthostatic hypotension, fainting spells or blackouts
  • Abnormal PT, TT, aPTT (must be within the normal range after no more than one repeated test), thrombocytes < 150000/μl (two repeats of the first test)
  • Evidence of hematuria either macroscopically detectable or microscopic on urinalysis (normal microscopic results after no more than one repeated test)
  • Evidence of blood dyscrasia, hemorrhagic diathesis, severe thrombocytopenia, cerebrovascular hemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with hemorrhagic tendencies (e.g. cerebral aneurysm, dissecting aorta, Central nervous system (CNS) trauma, retinopathy, nephrolithiasis)
  • Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery of CNS or eye or surgery resulting in large open surfaces) within 14 days before or after drug administration of this clinical trial
  • Occult blood in 1 of 3 subsequent faecal samples collected for the pre-study examination
  • Chronic or relevant acute infections
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
  • Use of any drugs, within 14 days prior to administration or during the trial
  • Participation in another trial with an investigational drug (< 2 months prior to administration or during trial)
  • Smoker (> 10 cigarettes or >3 cigars or >3 pipes/day)
  • Alcohol abuse (> 60 g/day)
  • Drug abuse
  • Blood donation or loss > 400 mL, < 1 month prior to administration or during the trial
  • Excessive physical activities < 5 days prior to administration of study drug or during trial
  • Clinically relevant laboratory abnormalities
  • Veins unsuited for i.v. puncture and administration of prolonged infusions on either arm (e.g. veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture, etc.)

Treatment and study plan

BIBT 986 BS - low

Drug

BIBT 986 BS - high

Drug

Placebo

Drug

Primary outcomes

  1. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: up to 48 hours post dose

  2. CT (concentration of the analyte at the end of drug infusion)

    Time frame: up to 48 hours post dose

  3. Css (steady state concentration of the analyte in plasma following a constant rate infusion)

    Time frame: up to 48 hours post dose

  4. Tmax (time from dosing to the maximum concentration of the analyte in plasma)

    Time frame: up to 48 hours post dose

  5. AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration)

    Time frame: up to 48 hours post dose

  6. t1/2 (Terminal half-life of the analyte in plasma after single dose administration)

    Time frame: up to 48 hours post dose

  7. AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration after single dose administration)

    Time frame: up to 48 hours post dose

  8. λz (terminal rate constant of the analyte in plasma)

    Time frame: up to 48 hours post dose

  9. MRTinf (mean residence time of the analyte in the body after intravenous infusion)

    Time frame: up to 48 hours post dose

  10. CL (Total clearance of the analyte in plasma following intravascular administration)

    Time frame: up to 48 hours post dose

  11. Vss (Apparent volume of distribution at steady state following intravascular administration)

    Time frame: up to 48 hours post dose

  12. Vz (apparent volume of distribution during the terminal phase λz following intravascular administration)

    Time frame: up to 48 hours post dose

  13. Amount of parent drug eliminated in urine (Ae)

    Time frame: up to 48 hours post dose

  14. Change in activated partial thromboplastin time (aPTT)

    Time frame: up to 48 hours post dose

  15. Change in prothrombin time (PT)

    Time frame: up to 48 hours post dose

  16. Change in ecarin clotting time (ECT)

    Time frame: up to 48 hours post dose

  17. Change in thrombin time (TT)

    Time frame: up to 48 hours post dose

  18. Number of subjects with adverse events

    Time frame: up to 4 days

  19. Number of subjects with clinically significant changes in vital signs

    Time frame: up to 4 days

    Pulse rate, systolic & diastolic blood pressure

  20. Change in International Normalised Ratio (INR)

    Time frame: up to 48 hours post dose

  21. Fraction of administered drug excreted unchanged in urine (fe)

    Time frame: up to 48 hours post dose

  22. CLR (renal clearance of the analyte in plasma following intravascular administration)

    Time frame: up to 48 hours post dose

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Tolerability and Pharmacokinetics/-Dynamics of 0.5 mg and 1.0 mg (Actual 0.8 mg) of BIBT 986 BS Per Hour Given as IV Infusion Over 32 Hours in Healthy Male Subjects. Placebo Controlled, Double Blind Randomised at Each Dose Level

Important dates

Study start
2003
Primary completion
2003
First posted
Oct 1, 2014
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.