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Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of BIBB 1464 MS in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food

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ClinicalTrials.gov Identifier: NCT02229838
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

Safety, pharmacodynamics and pharmacokinetics of 0.25, 0.75, 2.0, 6.0, and 10 mg BIBB 1464 p.o once daily in a rising dose group-comparison (placebo controlled, double blind, randomized per dose level).

Relative Bioavailability of 0.75 mg or 2 mg or 6 mg ( tablet vs. solution, intraindividual comparison), preliminary assessment of food effects (interindividual comparison)

Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).

MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase).


Condition or disease Intervention/treatment Phase
Healthy Drug: BIBB 1464 MS tablet Drug: BIBB 1464 MS solution Drug: BIBB 1464 MS placebo Other: Standard dinner Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of 0.25 mg, 0.75 mg, 2 mg, 6 mg, and 10 mg BIBB 1464 MS (Tablet) in Healthy Male Subjects, Combined With Preliminary Evaluation of Relative Bioavailability and Effect of Food of the Dose of 0.75 mg or 2 mg or 6 mg (Two-stage Trial Design With Randomised Double Blind Placebo Controlled Rising Dose Phase and Subsequent Randomised, Open Parallel Group Phase)
Study Start Date : July 1999
Actual Primary Completion Date : September 1999

Arm Intervention/treatment
Experimental: BIBB 1464 MS single rising dose fed Drug: BIBB 1464 MS tablet
Other: Standard dinner
Experimental: BIBB 1464 MS tablet fasted Drug: BIBB 1464 MS tablet
Active Comparator: BIBB 1464 MS solution fasted Drug: BIBB 1464 MS solution
Placebo Comparator: BIBB 1464 MS placebo Drug: BIBB 1464 MS placebo



Primary Outcome Measures :
  1. Maximum drug plasma concentration (Cmax) [ Time Frame: Up to 38 hours after drug administration ]
  2. Time to reach the maximum concentration of the analyte in plasma (tmax) [ Time Frame: Up to 38 hours after drug administration ]
  3. Total area under the plasma drug concentration-time curve (AUC) [ Time Frame: Up to 38 hours after drug administration ]
  4. Apparent terminal half-life of the analyte in plasma (t1/2) [ Time Frame: Up to 38 hours after drug administration ]
  5. Total plasma clearance divided by the systemic availability factor (CL/f) [ Time Frame: Up to 38 hours after drug administration ]
  6. Dose normalized AUC0-38h ( NAUC0-38h) [ Time Frame: Up to 38 h after drug administration ]
  7. Mean residence time, total (MRTtot) [ Time Frame: Up to 38 hours after drug administration ]
  8. Number of patients with adverse events [ Time Frame: Up to 72 hours after last drug administration ]
  9. Number of patients with clinical significant findings in vital signs [ Time Frame: Up to 38 hours after drug administration ]
  10. Number of patients with clinical significant findings in electrocardiogram (ECG) [ Time Frame: Up to 38 hours after drug administration ]
  11. Number of patients with clinical significant findings in physical examination [ Time Frame: Up to 38 hours after drug administration ]
  12. Investigator assessed tolerability on a 4 point scale [ Time Frame: Up to 38 hours after drug administration ]
  13. Monoepoxysqualene (MES) plasma concentration [ Time Frame: Up to 38 hours after drug administration ]
  14. Amount of drug excreted in urine [ Time Frame: Up to 38 h after drug administration ]


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Ages Eligible for Study:   19 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy 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
  • Broca > - 20% and < + 20%

Exclusion Criteria:

  • Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal (including thyroid) disorder
  • Surgery of the gastro-intestinal tract (except appendectomy)
  • Disease 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
  • 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 result of the trial (<= 10 days prior to administration or during the trial)
  • Participation in another trial with an investigational drug (<= 2 month prior to administration or during the trial)
  • Smoker (> 10 cigarettes or > 3 cigars or >3 pipes/day)
  • Inability to refrain from smoking during the period of the study
  • Known alcohol (>60 g/day) or drug abuse
  • Blood donation (<=1 month prior to administration)
  • Excessive physical activities (<5 days prior to administration)
  • Any laboratory value outside the normal range of clinical relevance
  • History of hemorrhagic diatheses
  • History of gastro-intestinal ulcer, perforation or bleeding
  • History of bronchial asthma

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02229838     History of Changes
Other Study ID Numbers: 1178.1
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014