Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Brief Summary:
To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a standardised high fat breakfast

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 14332 CL Other: high fat breakfast Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : September 2006
Actual Primary Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

Arm Intervention/treatment
Experimental: BI 14332 CL fasted Drug: BI 14332 CL
Experimental: BI 14332 CL fed Drug: BI 14332 CL
Other: high fat breakfast



Primary Outcome Measures :
  1. 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 ]
  2. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 192 hours after drug administration ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. tmax (time from dosing to the maximum concentration of the analyte in plasma) [ Time Frame: up to 192 hours after drug administration ]
  4. λz (terminal rate constant in plasma) [ Time Frame: up to 192 hours after drug administration ]
  5. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 192 hours after drug administration ]
  6. MRTpo (mean residence time of the analyte in the body after oral administration) [ Time Frame: up to 192 hours after drug administration ]
  7. CL/F (apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: up to 192 hours after drug administration ]
  8. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 192 hours after drug administration ]
  9. Number of patients with adverse events [ Time Frame: up to 23 days after last drug administration ]
  10. Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate) [ Time Frame: up to 23 days after last drug administration ]
  11. Number of patients with clinically significant findings in laboratory tests [ Time Frame: up to 23 days after last drug administration ]
  12. Number of patients with clinically significant findings in ECG [ Time Frame: up to 23 days after last drug administration ]
  13. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to 23 days after last drug administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older 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 ≥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)

Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02212938     History of Changes
Other Study ID Numbers: 1233.3
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014