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Relative Oral Bioavailability of BI 44847 as Suspension Compared to Tablet and the Influence of Food Anf of BI 44847 as Solution Compared to Tablet in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02211937
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to investigate the relative oral bioavailability of 400 mg BI 44847 as suspension vs. 400 mg BI 44847 as tablet, to investigate a food effect on the 400 mg tablet pharmacokinetic (PK) and to investigate relative oral bioavailability of 40 mg BI 44847 as solution vs. 40 mg BI 44847 as tablet.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 44847 solution, low dose Drug: BI 44847 suspension, high dose Drug: BI 44847 tablet, low dose Drug: BI 44847 tablet, high dose Other: high fat breakfast Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Oral Bioavailability of 400 mg BI 44847 as Suspension Compared to 400 mg BI 44847 as Tablet and the Influence of Food (Standardised High Fat Breakfast) on the Tablet in a Single Dose, Open-label, Randomised Three-way Crossover Trial and Relative Oral Bioavailability of 40 mg BI 44847 as Solution Compared to 40 mg BI 44847 as Tablet in Healthy Male Volunteers in a Single Dose, Open-label, Randomised Two-way Crossover Trial
Study Start Date : January 2007
Actual Primary Completion Date : March 2007

Arm Intervention/treatment
Active Comparator: Treatment A
BI 44847 suspension high dose, fasted
Drug: BI 44847 suspension, high dose
Experimental: Treatment B
BI 44847 tablet high dose, fasted
Drug: BI 44847 tablet, high dose
Experimental: Treatment C
BI 44847 tablet high dose, fed
Drug: BI 44847 tablet, high dose
Other: high fat breakfast
Active Comparator: Treatment D
BI 44847 solution low dose, fasted
Drug: BI 44847 solution, low dose
Experimental: Treatment E
BI 44847 tablet low dose, fasted
Drug: BI 44847 tablet, low dose



Primary Outcome Measures :
  1. Cmax (maximum concentration of the analyte in plasma) [ Time Frame: up to 48 hours after drug administration ]
  2. 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 48 hours after drug administration ]
  3. 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 48 hours after drug administration ]

Secondary Outcome Measures :
  1. λz (terminal rate constant in plasma) [ Time Frame: up to 48 hours after drug administration ]
  2. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 48 hours after drug administration ]
  3. MRTpo (mean residence time of the analyte in the body after po administration) [ Time Frame: up to 48 hours after drug administration ]
  4. CL/F (total clearance of the analyte in the plasma after extravascular administration) [ Time Frame: up to 48 hours after drug administration ]
  5. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 48 hours after drug administration ]
  6. Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 48 hours after drug administration ]
  7. 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 ]
  8. 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 ]
  9. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: up to 48 hours after drug administration ]
  10. tmax (time from dosing to maximum concentration) [ Time Frame: up to 48 hours after drug administration ]
  11. Number of patients with clinically relevant changes in vital signs [ Time Frame: up to 3 days after last drug administration ]
  12. Number of patients with clinically relevant findings in 12-lead electrocardiogram (ECG) [ Time Frame: up to 3 days after last drug administration ]
  13. Number of patients with adverse events [ Time Frame: up to 3 days after last drug administration ]
  14. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: day 3 ]


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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:

  • 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 ≤ 50 years
  • BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice 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
  • 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 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 study centre
  • Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval > 120 ms. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 450 ms or QT> 500 ms)
  • A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • The use of concomitant medications that prolong the QT/QTc interval

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02211937     History of Changes
Other Study ID Numbers: 1224.2
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Pharmaceutical Solutions