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Safety, Tolerability and Pharmacokinetics of BI 34021 FU2 Oral Drinking Solution in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02259842
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Evaluation of safety, tolerability and PK of single rising oral doses of BI 34021 FU2 in healthy male volunteers; comparison of 100 mg drinking solution vs. tablet, assessment of food effect by re-dosing at 50 mg and 150 mg

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 34021 FU2 solution Drug: BI 34021 FU2 tablet Drug: Placebo Other: High fat, high calorie breakfast Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of BI 34021 FU2 Oral Drinking Solution in Healthy Male Volunteers (Dose Range: 5 - 500 mg). A Double-blind (Within Dose Groups), Randomised, Placebo-controlled Within Dose Groups, Single Rising Dose Study, Including Re-dosing at 50 mg and 150 mg (Food Effect) and at 100 mg (Two 50 mg Tablets)
Study Start Date : March 2008
Actual Primary Completion Date : June 2008

Arm Intervention/treatment
Experimental: BI 34021 FU2 solution
single rising doses, dose groups 3 and 5 double-dosing (fed and fasted)
Drug: BI 34021 FU2 solution
Other: High fat, high calorie breakfast
only for dose groups 3 and 5

Experimental: BI 34021 FU2 tablet
dose group 4 only
Drug: BI 34021 FU2 tablet
dose group 4 only

Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of participants with clinically significant findings on physical examination [ Time Frame: up to 10 days after last drug administration ]
  2. Number of participants with clinically significant findings in vital signs [ Time Frame: up to 10 days after last drug administration ]
    blood pressure (BP), pulse rate (PR) respiratory rate (RR), oral body temperature, orthostatic test

  3. Number of participants with clinically significant findings in 12-lead electrocardiogram (ECG) [ Time Frame: up to 10 days after last drug administration ]
  4. Number of participants with clinically significant findings in laboratory tests [ Time Frame: up to 10 days after last drug administration ]
  5. Number of participants with clinically significant findings in safety markers [ Time Frame: up to 10 days after last drug administration ]
    laboratory results for kidney and liver function

  6. Number of participants with adverse events [ Time Frame: up to 10 days after last drug administration ]
  7. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to 10 days after last drug administration ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 72 hours after last drug administration ]
  2. tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 72 hours after last 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 72 hours after last drug administration ]
  4. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: up to 72 hours after last drug administration ]
  5. 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 72 hours after last drug administration ]
  6. AUC0-2h (area under the concentration-time curve of the analytes in plasma over the time interval 0 to 2 hours after drug administration) [ Time Frame: up to 2 hours after last drug administration ]
  7. λz (terminal rate constant in plasma) [ Time Frame: up to 72 hours after last drug administration ]
  8. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours after last drug administration ]
  9. MRTp.o. (mean residence time of the analyte in the body after p.o. administration) [ Time Frame: up to 72 hours after last drug administration ]
  10. CL/F (total/apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: up to 72 hours after last drug administration ]
  11. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 72 hours after last drug administration ]
  12. Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 48 hours after last drug administration ]
  13. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: up to 48 hours after last drug administration ]
  14. 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 last drug administration ]


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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 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
  2. Age ≥21 and Age ≤50 years
  3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
  4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

  1. Any finding of the medical examination (including BP, PR and 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. 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 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
  11. Participation in another trial with an investigational drug within two months 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 trial)
  18. Any laboratory value outside the reference range that is of clinical relevance
  19. Inability to comply with dietary regimen of trial site
  20. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  21. A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  22. Not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device (IUD) during the whole study period from the time of the first intake of study drug until three months after the last intake

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02259842     History of Changes
Other Study ID Numbers: 1258.1
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: October 9, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Pharmaceutical Solutions