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Safety, Pharmacodynamics, and Pharmacokinetics of BIBT 1011 BS in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02182037
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
A study to assess safety, pharmacokinetics and the effect of BIBT 986 BS, given as BIBT 1011 BS, on coagulation parameters.

Condition or disease Intervention/treatment Phase
Healthy Drug: Single rising doses of BIBT 1011 BS Drug: BIBT 1011 BS placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Pharmacodynamics, and Pharmacokinetics After Single Oral Administration of 1, 5, 10, 30, 100, 200 and 400 mg BIBT 1011 BS as Drinking Solution in Healthy Subjects. An Open, Placebo-controlled, Randomised Study, Double Blind at Each Dose Level
Study Start Date : August 2001
Actual Primary Completion Date : September 2001

Arm Intervention/treatment
Experimental: BIBT 1011 BS Drug: Single rising doses of BIBT 1011 BS
Placebo Comparator: BIBT 1011 BS placebo Drug: BIBT 1011 BS placebo



Primary Outcome Measures :
  1. Determination of activated partial thromboplastin time (aPTT) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  2. Determination of international normalized ration (INR) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]

Secondary Outcome Measures :
  1. Determination of thrombin time (TT) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  2. Determination of ecarin clotting time (ECT) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  3. Assessment of plasma concentration time profiles of BIBT 986 BS [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  4. Maximum concentration of BIBT 986 BS in plasma (Cmax) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  5. Area under the concentration time curve for BIBT 986 BS (AUC) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  6. Time from dosing to when the plasma concentration reaches Cmax after a single extravascular dose (tmax) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  7. Total mean time of residence of BIBT 986 BS- molecules in the body (MRTtot) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  8. Apparent volume of distribution of the analytes during the terminal phase (Vz/f) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  9. Terminal elimination half life of BIBT 986 BS in plasma (t1/2) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  10. Amount excreted over the 24 hour sampling period (Ae0-24) [ Time Frame: Pre-dose, up to 24 hours after start of treatment ]
  11. Total clearance after oral administration (CLtot/F) [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]
  12. Number of patients with adverse events [ Time Frame: Up to 17 days ]
  13. Assessment of BIBT 986 BS plasma concentration- aPTT relationship [ Time Frame: Pre-dose, up to 48 hours after start of treatment ]


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Ages Eligible for Study:   18 Years to 45 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 ≤ 45 years
  • Body Mass Index ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

  • Any finding 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, immunological, hormonal disorders
  • History of orthostatic hypotension, fainting spells or 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 the 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

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182037    
Other Study ID Numbers: 1193.1
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014