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Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW in Healthy Male Volunteers.

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ClinicalTrials.gov Identifier: NCT02183662
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate safety and pharmacokinetics of BI 224436 ZW

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 224436 Drug: Placebo to BI 224436 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety and Pharmacokinetics of Single Rising Oral Doses of BI 224436 ZW at 6.2 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg Dose Levels in Healthy Male Volunteers (Randomized, Double-blind, Placebo-controlled Within Dose Groups)
Study Start Date : November 2009
Actual Primary Completion Date : March 2010

Arm Intervention/treatment
Experimental: BI 224436 Drug: BI 224436
Placebo Comparator: Placebo Drug: Placebo to BI 224436



Primary Outcome Measures :
  1. maximum measured concentration of the analyte in plasma [ Time Frame: up to 72 hours ]
  2. area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24 [ Time Frame: up to 24 hours ]

Secondary Outcome Measures :
  1. 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 ]
  2. minimum observed concentration at 24 hours [ Time Frame: up to 24 hours ]
  3. terminal half-life of the analyte in plasma [ Time Frame: up to 72 hours ]
  4. time from dosing to maximum measured concentration of the analyte in plasma [ Time Frame: up to 72 hours ]
  5. apparent clearance of the analyte in plasma [ Time Frame: up to 72 hours ]
  6. apparent volume of distribution during the terminal phase λz [ Time Frame: up to 72 hours ]
  7. apparent volume of distribution [ Time Frame: up to 72 hours ]
  8. mean residence time of the analyte in the body after single oral administration [ Time Frame: up to 72 hours ]
  9. terminal rate constant in plasma [ Time Frame: up to 72 hours ]
  10. the last measurable concentration in the concentration-time profile [ Time Frame: up to 72 hours ]
  11. the extrapolated Area under the curve from the time of the last measurable concentration in the concentration-time profile to infinity [ Time Frame: up to 72 hours ]
  12. the percentage of the Area under the concentration-time curve until infinity, that is determined by extrapolation [ Time Frame: up to 72 hours ]
  13. amount of analyte that is eliminated in urine from the time point t0 to time point t4 [ Time Frame: up to 4 hours ]
  14. amount of analyte that is eliminated in urine from the time point t4 to time point t8 [ Time Frame: from 4 to 8 hours ]
  15. amount of analyte that is eliminated in urine from the time point t8 to time point t12 [ Time Frame: from 8 to 12 hours ]
  16. amount of analyte that is eliminated in urine from the time point t12 to time point t24 [ Time Frame: from 12 to 24 hours ]
  17. fraction of analyte eliminated in urine from time point t0 to time point t24 [ Time Frame: up to 24 hours ]
  18. renal clearance of the analyte from the time point t0 until the time point t24 [ Time Frame: up to 24 hours ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males
  2. Age ≥21 and Age ≤50 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 Good clinical practice (GCP) and the local legislation.

Exclusion Criteria:

  1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Surgery of the gastrointestinal tract (except appendectomy)
  5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  6. History of relevant orthostatic hypotension, fainting spells or blackouts
  7. HIV infection and other chronic or relevant acute infections
  8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  9. 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
  10. Use of drugs which might reasonably influence the results of the trial within 10 days prior to administration or during the trial
  11. Participation in another trial with an investigational drug within one month prior to administration or during the trial
  12. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
  13. Inability to refrain from smoking on trial days
  14. Alcohol abuse (more than 60 g/day)
  15. Drug abuse
  16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  17. Excessive physical activities (within one week prior to administration or during the treatment period)
  18. Any laboratory value outside the reference range that is of clinical relevance
  19. A baseline prolongation of QT/QTc interval (e.g., a QTc interval ≥450 ms)
  20. A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  21. Bradycardia (PR <60 beats/min)

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183662    
Other Study ID Numbers: 1277.1
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014