Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02254083
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 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

Condition or disease Intervention/treatment Phase
Healthy Drug: BIBT 986 BS - low Drug: BIBT 986 BS - high Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : February 2003
Actual Primary Completion Date : May 2003

Arm Intervention/treatment
Experimental: BIBT 986 BS - low Drug: BIBT 986 BS - low
Experimental: BIBT 986 BS - high Drug: BIBT 986 BS - high
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
  • 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.)
Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02254083    
Other Study ID Numbers: 1192.2
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014