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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 11634 Solution in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02214914
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
First evaluation of safety, tolerability, pharmacokinetics and the pharmacodynamic effect of BI 11634 on coagulation parameters

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 11634 drinking solution Drug: BI 11634 tablet Drug: 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, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 5, 10, 25, 50, 100, 200 and 400 mg BI 11634 Solution Administered to Healthy Male Volunteers. Randomised, Double-blind, Placebo Controlled at Each Dose Level. Intra-individual Comparison of Solution to an Immediate Release Tablet Formulation at One Dose Level (50 mg)
Study Start Date : November 2006
Actual Primary Completion Date : March 2007

Arm Intervention/treatment
Experimental: BI 11634 drinking solution
single rising dose
Drug: BI 11634 drinking solution
Placebo Comparator: Placebo Drug: Placebo
Experimental: BI 11634 tablet Drug: BI 11634 tablet



Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: up to 10 days after drug administration ]
  2. Number of subjects with clinically significant findings in vital signs (blood pressure, pulse rate) [ Time Frame: up to 10 days after drug administration ]
  3. Number of subjects with clinically significant findings in ECG [ Time Frame: up to 10 days after drug administration ]
  4. Number of subjects with clinically significant findings laboratory tests [ Time Frame: up to 10 days after drug administration ]
  5. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to 10 days after drug administration ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 hours after drug administration ]
  2. tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 72 hours after drug administration ]
  3. AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 72 hours after drug administration ]
  4. AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point) [ Time Frame: up to 72 hours after drug administration ]
  5. λz (terminal rate constant in plasma) [ Time Frame: up to 72 hours after drug administration ]
  6. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours after drug administration ]
  7. MRTpo (mean residence time of the analyte in the body after oral administration) [ Time Frame: up to 72 hours after drug administration ]
  8. CL/F (apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: up to 72 hours after drug administration ]
  9. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 72 hours after drug administration ]
  10. Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 48 hours after drug administration ]
  11. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: up to 48 hours after drug administration ]
  12. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: up to 48 hours after drug administration ]
  13. Activated partial thromboplastin time (aPTT) ratios between groups [ Time Frame: up to 72 hours after drug administration ]
  14. Maximum aPTT prolongation [ Time Frame: up to 72 hours after drug administration ]
    compared between groups

  15. Maximum international normalized ratio (INR) [ Time Frame: up to 72 hours after drug administration ]
    compared between groups

  16. % inhibition of endogenous Factor Xa [ Time Frame: up to 72 hours after drug administration ]
    by Russel's Viper Venom test (RVV)

  17. Percent inhibition of thrombin generation by BI 11634 [ Time Frame: up to 24 hours after drug administration ]
  18. Percent peak inhibition of thrombin generation [ Time Frame: up to 24 hours after drug administration ]
  19. Time to maximum inhibition of thrombin generation BI 11634 [ Time Frame: up to 24 hours after drug administration ]
  20. Percent prolongation of lag time [ Time Frame: up to 24 hours after drug administration ]
  21. Area under the inhibition of the endogenous thrombin generation-time curve [ Time Frame: up to 24 hours after drug administration ]
  22. Maximum prolongation of blood coagulation time [ Time Frame: up to 72 hours after drug administration ]
    by HepTest® (Haemachem Inc.) and COAMATIC® Heparin test (Chromogenix)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males according to the following criteria:

Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests

  • Age ≥18 and ≤50 years
  • Haemoglobin within the normal ranges
  • Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation

Exclusion Criteria:

  • Relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Relevant surgery of gastrointestinal tract
  • History of any bleeding disorder or acute blood coagulation defect, for the subject itself or any person of his family as far as known
  • History of gastric ulcera and cholecystectomy
  • Occult blood in feces
  • Relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells or blackouts
  • Relevant chronic or 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) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  • 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
  • Use of acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (NSAID) within 2 weeks of study start until the end of study
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Alcohol abuse (more than 40 g/day)
  • Drug abuse
  • Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  • Excessive physical activities (within one week prior to administration or during the trial)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Vulnerable subjects (e.g. persons kept in detention)
  • The subject is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
  • Subjects with a history within the past 2 weeks of closed head or torso trauma or deceleration injury such as an automobile accident or fall from a significant height

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02214914     History of Changes
Other Study ID Numbers: 1234.1
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Pharmaceutical Solutions