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Safety, Tolerability and Pharmacokinetics of BI 44370 TA Oral Drinking Solution in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02215018
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To evaluate the safety, tolerability and pharmacokinetics of single rising oral doses of BI 44370 TA in healthy male volunteers, to compare a drinking solution vs. a tablet formulation and to assess intra-individual pharmacokinetic (PK) variability by re-dosing two further doses.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 44370 TA solution Drug: BI 44370 TA tablet Drug: Placebo solution Drug: Placebo tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of BI 44370 TA Oral Drinking Solution in Healthy Male Volunteers (Dose Range: 5 - 800 mg). A Double-blind (Within Dose Groups), Randomised, Placebo-controlled Within Dose Groups, Single Rising Dose Study, Including Re-dosing at 100 mg and 500 mg (Solution) and at 200 mg (Four 50 mg Tablets)
Study Start Date : April 2007
Actual Primary Completion Date : August 2007

Arm Intervention/treatment
Experimental: BI 44370 TA solution Drug: BI 44370 TA solution
Experimental: BI 44370 TA tablet Drug: BI 44370 TA tablet
Placebo Comparator: Placebo solution Drug: Placebo solution
Placebo Comparator: Placebo tablet Drug: Placebo tablet



Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: up to 10 days after last drug administration ]
  2. Number of patients with clinically significant findings in vital signs [ Time Frame: up to 10 days after last drug administration ]
  3. Number of patients with clinically significant findings in laboratory tests [ Time Frame: up to 10 days after last drug administration ]
  4. Number of patients with clinically significant findings in ECG [ Time Frame: up to 10 days after last drug administration ]
  5. 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 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. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: up to 72 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 72 hours after drug administration ]
  6. AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2) [ Time Frame: up to 72 hours after drug administration ]
  7. tz (time of last measurable concentration of the analyte in plasma) [ Time Frame: up to 72 hours after drug administration ]
  8. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 72 hours after drug administration ]
  9. MRTp.o. (mean residence time of the analyte in the body after oral administration) [ Time Frame: up to 72 hours after drug administration ]
  10. CL/F (total/apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: up to 72 hours after drug administration ]
  11. Vz/F (apparent volume of distribution during the terminal phase tz following an extravascular dose) [ Time Frame: up to 72 hours after drug administration ]
  12. λz (the terminal rate constant) [ Time Frame: up to 72 hours after drug administration ]
  13. Aet1/t2 (total quantity of analyte excreted in the urine in the time interval from t1 to t2) [ Time Frame: up to 24 hours after drug administration ]
  14. fet1/t2 (the fractional excretion of the analyte in the time interval from t1 to t2) [ Time Frame: up to 24 hours after drug administration ]
  15. CLR,t1/t2 (the renal clearance of the analyte in the time interval from t1 to t2) [ Time Frame: up to 24 hours after 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, RR and body temperature), 12-lead ECG, clinical laboratory tests

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

Exclusion Criteria:

  1. Any finding of the medical examination (including Blood Pressure (BP), Pulse Rate (PR), Respiratory rate (RR) , body temperature and Electrocardiogram(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) 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: NCT02215018     History of Changes
Other Study ID Numbers: 1246.1
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Pharmaceutical Solutions