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

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ClinicalTrials.gov Identifier: NCT02254057
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0, 2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion and to assess the effect of BIBT 986 BS on blood coagulation parameters

Condition or disease Intervention/treatment Phase
Healthy Drug: BIBT 986 BS - single rising dose Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Tolerability and Pharmacokinetics/-Dynamics of Single Rising Doses of 0.1 mg, 0.3 mg, 1.0 mg, 2.5 mg, 5.0 mg, and 10.0 mg BIBT 986 BS (IV Infusion Over 30 Minutes) in Healthy Male Subjects. Placebo Controlled, Double Blind Randomised at Each Dose Level
Study Start Date : July 2002
Actual Primary Completion Date : October 2002

Arm Intervention/treatment
Experimental: BIBT 986 BS - single rising dose Drug: BIBT 986 BS - single rising dose
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. 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 after start of infusion ]
  2. 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 after start of infusion ]
  3. C29 (plasma concentration of BIBT 986 BS at the end of infusion) [ Time Frame: 29 minutes after start of infusion ]
  4. t1/2 (Terminal half-life of the analyte in plasma after single dose administration) [ Time Frame: up to 48 hours after start of infusion ]
  5. CL (Total clearance of the analyte in plasma following intravascular administration) [ Time Frame: up to 48 hours after start of infusion ]
  6. Vss (Apparent volume of distribution at steady state following intravascular administration) [ Time Frame: up to 48 hours after start of infusion ]
  7. urinary excretion of BIBT 986 BS [ Time Frame: up to 48 hours after start of infusion ]
  8. CLR (Renal clearance of the analyte in plasma following intravascular administration) [ Time Frame: up to 48 hours after start of infusion ]
  9. MRT (Mean residence time of drug molecules in the body after intravascular administration) [ Time Frame: up to 48 hours after start of infusion ]
  10. Change in activated partial thromboplastin time (aPTT) [ Time Frame: up to 48 hours after start of infusion ]
  11. Change in International Normalised Ratio (INR) [ Time Frame: up to 48 hours after start of infusion ]
  12. Change in ecarin clotting time (ECT) [ Time Frame: up to 48 hours after start of infusion ]
  13. Change in thrombin time (TT) [ Time Frame: up to 48 hours after start of infusion ]
  14. Number of patients with clinically significant findings in vital signs [ Time Frame: up to 48 hours after start of infusion ]
    pulse rate, blood pressure

  15. Number of patients with clinically significant findings in electrocardiogram [ Time Frame: up to 48 hours after start of infusion ]
  16. Number of patients with clinically significant findings in laboratory tests [ Time Frame: up to 48 hours after start of infusion ]
  17. Number of patients with adverse events [ Time Frame: up to 48 hours after start of infusion ]
  18. Number of patients with histamine in blood [ Time Frame: up to 48 hours after start of infusion ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  • Any bleeding disorder including prolonged or habitual bleeding
  • History of other hematologic disease, cerebral bleeding (e.g. after a car accident), commotio cerebri
  • Chronic or relevant acute infections
  • History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  • Seasonal rhinitis
  • Thrombocytes < 150000/μl
  • Intake of drugs with a long half-life (> 24 hours) (< 1 month prior to administration or during the trial)
  • Use of any drugs, which might influence the results of the trial (< 10 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
  • Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco < 5 days prior to administration of study drug or during trial
  • 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
  • Any ECG value outside of the reference range of clinical relevance including, but not limited to QRS interval > 110 ms or QTcB > 450 ms
  • Inability to comply with dietary regimen of study centre
  • Inability to comply with investigator's instructions
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02254057    
Other Study ID Numbers: 1192.1
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014