Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 44847 Powder in Healthy Male Subjects

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: NCT02209844
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 44847 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (2.5 mg to 1200 mg) of BI 44847 as Powder in the Bottle Reconstituted With 0.2% Natrosol Solution Administered to Healthy Male Subjects. A Randomised, Placebo-controlled (Within Dose Groups) and Double-blinded Trial
Study Start Date : August 2006
Actual Primary Completion Date : January 2007

Arm Intervention/treatment
Experimental: BI 44847 powder
single rising dose reconstituted with natrosol solution
Drug: BI 44847
Placebo Comparator: Placebo
reconstituted with natrosol solution
Drug: Placebo



Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: up to day 12 ]
  2. Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate) [ Time Frame: up to day 12 ]
  3. Number of patients with clinically significant findings in ECG [ Time Frame: up to day 12 ]
  4. Number of patients with clinically significant laboratory findings [ Time Frame: up to day 12 ]
  5. Assessment of tolerability by the investigator on a 4-point scale [ Time Frame: up to day 12 ]

Secondary Outcome Measures :
  1. Cmax (maximum concentration of the analyte in plasma) [ Time Frame: up to 96 hours after drug administration ]
  2. tmax (time from dosing to maximum concentration) [ Time Frame: up to 96 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 96 hours after drug administration ]
  4. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: up to 96 hours after 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 96 hours after drug administration ]
  6. λz (terminal rate constant in plasma) [ Time Frame: up to 96 hours after drug administration ]
  7. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 96 hours after drug administration ]
  8. MRTpo (mean residence time of the analyte in the body after oral administration) [ Time Frame: up to 96 hours after drug administration ]
  9. CL/F (total clearance of the analyte in the plasma after extravascular administration) [ Time Frame: up to 96 hours after drug administration ]
  10. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 96 hours after drug administration ]
  11. Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) [ Time Frame: up to 72 hours after drug administration ]
  12. 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 ]
  13. 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 ]
  14. Area under the plasma glucose concentration time curve [ Time Frame: up to 96 hours after drug administration ]
  15. Total amount of glucose excreted in urine [ Time Frame: up to 72 hours after drug administration ]
  16. Maximum glucose concentration in plasma [ Time Frame: up to 96 hours after drug administration ]
  17. Maximum glucose concentration in urine [ Time Frame: up to 72 hours after 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:   18 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, HR), 12-lead ECG, clinical laboratory tests

  2. Age ≥ 18 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, pulse rate 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. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  5. History of relevant orthostatic hypotension, fainting spells or blackouts
  6. Chronic or relevant acute infections
  7. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  8. 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
  9. 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
  10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  11. Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  12. Inability to refrain from smoking on trial days
  13. Alcohol abuse (more than 60 g/day)
  14. Drug abuse
  15. Blood donation (more than 100 mL) within four weeks prior to administration or during the trial
  16. Excessive physical activities (within one week prior to administration or during the trial)
  17. Any laboratory value outside the reference range that is of clinical relevance
  18. Inability to comply with dietary regimen of study centre
  19. 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).
  20. A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  21. The use of concomitant medications that prolong the QT/QTc interval
  22. Elevated urinary glucose levels at screening (> 15 mg/dl)

Additional Information:
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02209844     History of Changes
Other Study ID Numbers: 1224.1
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Pharmaceutical Solutions