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Influence of a Standardised High Fat Breakfast on the Bioavailability of BI 14332 CL in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02212938
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE August 7, 2014
First Posted Date  ICMJE August 8, 2014
Last Update Posted Date August 8, 2014
Study Start Date  ICMJE September 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
  • AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 192 hours after drug administration ]
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 192 hours after drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
  • AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: up to 192 hours after drug administration ]
  • AUCt1-t2 (partial area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2) [ Time Frame: up to 192 hours after drug administration ]
  • tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: up to 192 hours after drug administration ]
  • λz (terminal rate constant in plasma) [ Time Frame: up to 192 hours after drug administration ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 192 hours after drug administration ]
  • MRTpo (mean residence time of the analyte in the body after oral administration) [ Time Frame: up to 192 hours after drug administration ]
  • CL/F (apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: up to 192 hours after drug administration ]
  • Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 192 hours after drug administration ]
  • Number of patients with adverse events [ Time Frame: up to 23 days after last drug administration ]
  • Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate) [ Time Frame: up to 23 days after last drug administration ]
  • Number of patients with clinically significant findings in laboratory tests [ Time Frame: up to 23 days after last drug administration ]
  • Number of patients with clinically significant findings in ECG [ Time Frame: up to 23 days after last drug administration ]
  • Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to 23 days after last drug 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 Influence of a Standardised High Fat Breakfast on the Bioavailability of BI 14332 CL in Healthy Male Volunteers
Official Title  ICMJE Influence of a Standardised High Fat Breakfast on the Bioavailability of 10 mg BI 14332 CL Taken as Two Tablets of 5 mg q.d. in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)
Brief Summary To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a standardised high fat breakfast
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: BI 14332 CL
  • Other: high fat breakfast
Study Arms  ICMJE
  • Experimental: BI 14332 CL fasted
    Intervention: Drug: BI 14332 CL
  • Experimental: BI 14332 CL fed
    Interventions:
    • Drug: BI 14332 CL
    • Other: high fat breakfast
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: August 7, 2014)
12
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ≥21 and Age ≤65 years
  • 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 GCP and the local legislation

Exclusion Criteria:

  • Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the gastrointestinal tract (except appendectomy)
  • Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  • History of relevant orthostatic hypotension, fainting spells or blackouts
  • Chronic or relevant acute infections
  • History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  • 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 or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 60 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
  • Inability to comply with dietary regimen of trial site
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  • A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 65 Years   (Adult, Older 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 NCT02212938
Other Study ID Numbers  ICMJE 1233.3
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 August 2014

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