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Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113823 Powder in Bottle (PiB) and Tablet in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02259972
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate the safety, tolerability, and pharmacokinetics incl. dose proportionality of BI 113823, as well as the relative bioavailability of PiB vs. tablet and tablet fasted vs. fed (food effect for the tablet).

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 113823 solution Drug: BI 113823 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: Investigation of Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of 5 to 800 mg BI 113823 Powder in Bottle (PiB) and Tablet Administered to Healthy Male Volunteers in a Partially Randomised and Double Blinded, Placebo Controlled Phase I Trial. Including Intra-individual Open Comparisons of PiB and Tablet (Fasted and Fed).
Study Start Date : January 2010
Actual Primary Completion Date : June 2010

Arm Intervention/treatment
Experimental: BI 113823 solution
single rising doses, dose group 5 twice (fed and fasted)
Drug: BI 113823 solution
Other: High fat, high calorie breakfast
only for dose group 5

Experimental: BI 113823 tablet
dose group 5 only
Drug: BI 113823 tablet
Other: High fat, high calorie breakfast
only for dose group 5

Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Number of participants with clinically significant findings on physical examination [ Time Frame: up to 14 days after last drug administration ]
  2. Number of participants with clinically significant findings in vital signs [ Time Frame: up to 14 days after last drug administration ]
    blood pressure (BP), pulse rate (PR)

  3. Number of participants with clinically significant findings in 12-lead electrocardiogram (ECG) [ Time Frame: up to 14 days after last drug administration ]
    special attention to QRS prolongation

  4. Number of participants with clinically significant findings in laboratory tests [ Time Frame: up to 14 days after last drug administration ]
  5. Number of participants with adverse events [ Time Frame: up to 14 days after last drug administration ]
  6. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to 14 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 drug administration ]
  2. tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 72 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 72 hours after drug administration ]
  4. AUC0-tz (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point) [ Time Frame: up to 72 hours after drug administration ]
  5. λz (terminal rate constant in plasma) [ Time Frame: up to 72 hours after drug administration ]
  6. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours after drug administration ]
  7. MRToral (mean residence time of the analyte in the body after oral administration) [ Time Frame: up to 72 hours after drug administration ]
  8. CL/F (total/apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: up to 72 hours after drug administration ]
  9. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 72 hours after drug administration ]
  10. Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 72 hours after drug administration ]
  11. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) [ Time Frame: up to 72 hours after drug administration ]
  12. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) [ Time Frame: up to 72 hours after drug administration ]


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Ages Eligible for Study:   18 Years to 45 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 ≥18 and Age ≤45 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 GCP 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
  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
  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 30 g/day)
  15. Drug abuse
  16. Blood donation (more than 100 mL within four weeks prior to administration)
  17. Excessive physical activities (within one week prior to administration)
  18. Any laboratory value outside the reference range that is of clinical relevance
  19. Inability to comply with dietary regimen of trial site
  20. Bradycardia < 50/min, PR interval > 200 ms, QRS interval > 110 ms, QTcB > 450 ms, or QT (uncorrected) > 470 ms or any other relevant ECG findings at screening
  21. A history of additional risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02259972     History of Changes
Other Study ID Numbers: 1272.1
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