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Safety, Pharmacodynamics and Pharmacokinetics After Single Oral Administration of Dabigatran Etexilate Capsule in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02171455
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE June 20, 2014
First Posted Date  ICMJE June 24, 2014
Last Update Posted Date June 24, 2014
Study Start Date  ICMJE January 2006
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
Frequency [N (%)] of subjects with adverse events [ Time Frame: up to 18 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2014)
  • Cmax (maximum measured concentration of free and total BIBR 953 ZW in plasma) [ Time Frame: up to 72 hours after administration ]
  • tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 72 hours after administration ]
  • AUC0-∞ (area under the concentration-time curve of free and total BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 72 hours after administration ]
  • λz (terminal rate constant in plasma) [ Time Frame: up to 72 hours after administration ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours after administration ]
  • MRTpo (mean residence time of the analyte in the body after oral administration) [ Time Frame: up to 72 hours after administration ]
  • CL/F (apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: up to 72 hours after administration ]
  • Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 72 hours after administration ]
  • Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 72 hours after administration ]
  • fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: up to 72 hours after administration ]
  • CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: up to 72 hours after administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Pharmacodynamics and Pharmacokinetics After Single Oral Administration of Dabigatran Etexilate Capsule in Healthy Subjects
Official Title  ICMJE Safety, Pharmacodynamics and Pharmacokinetics After Single Oral Administration of 600 mg, 750 mg and 900 mg Dabigatran Etexilate as Capsule in Healthy Subjects. A Randomised, Placebo-controlled Study, Double Blind at Each Dose Level
Brief Summary To assess safety, pharmacokinetics and the effect of dabigatran on coagulation parameters prior to administration of a high dose of dabigatran etexilate in a QT study
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Dabigatran etexilate low dose
  • Drug: Dabigatran etexilate medium dose
  • Drug: Dabigatran etexilate high dose
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Dabigatran etexilate low dose
    Interventions:
    • Drug: Dabigatran etexilate low dose
    • Drug: Placebo
  • Experimental: Dabigatran etexilate medium dose
    Interventions:
    • Drug: Dabigatran etexilate medium dose
    • Drug: Placebo
  • Experimental: Dabigatran etexilate high dose
    Interventions:
    • Drug: Dabigatran etexilate high dose
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2014)
10
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
  2. Age ≥18 and ≤55 years
  3. Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
  4. Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.

Exclusion Criteria:

  1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  2. Relevant surgery of gastrointestinal tract
  3. History of any bleeding disorder or acute blood coagulation defect
  4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  5. History of relevant orthostatic hypotension, fainting spells or blackouts
  6. Chronic or relevant acute infections
  7. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  8. Intake of drugs with a long half-life (>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
  10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  11. Alcohol abuse (more than 60 g/day)
  12. Drug abuse
  13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  14. Excessive physical activities (within one week prior to administration or during the trial)
  15. Any laboratory value outside the reference range that is of clinical relevance
  16. Inability to comply with dietary regimen of study centre
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02171455
Other Study ID Numbers  ICMJE 1160.60
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP