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Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 44370 TA Tablets in Healthy Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT02215759
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Evaluation of safety, tolerability and pharmacokinetics of multiple rising oral doses of BI 44370 TA in healthy male and female volunteers

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 44370 TA Tablets (100 mg, 200 mg and 300 mg Three Times Every Two Hours on One Day and q.d. for Another 2 to 3 Days) in Healthy Male and Female Volunteers, a Randomised, Doubleblind, Placebo-controlled Within Dose Groups Phase I Study
Study Start Date : January 2009
Actual Primary Completion Date : June 2009

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



Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: up to 36 days ]
  2. Number of patients with clinically relevant findings in vital signs [ Time Frame: up to 7 days after last drug administration ]
  3. Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram) [ Time Frame: up to 7 days after last drug administration ]
  4. Number of patients with clinically relevant laboratory findings [ Time Frame: up to 7 days after last drug administration ]
  5. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: up to 7 days after last drug administration ]

Secondary Outcome Measures :
  1. Maximum measured concentration of the analyte in plasma (Cmax ) for several time points [ Time Frame: up to 4 days ]
  2. Time from dosing to maximum measured concentration of the analyte in plasma (tmax) for several time points [ Time Frame: up to 4 days ]
  3. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC) for several time points [ Time Frame: up to 4 days ]
  4. The percentage of the AUC 0-∞ that is obtained by extrapolation (%AUCtz-∞) for several time points [ Time Frame: up to 4 days ]
  5. Terminal rate constant in plasma (λz) for several time points [ Time Frame: up to 4 days ]
  6. Terminal half-life of the analyte in plasma (t1/2) for several time points [ Time Frame: up to 4 days ]
  7. Mean residence time of the analyte in the body after p.o. administration (MRTpo) for several time points [ Time Frame: up to 4 days ]
  8. Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for several time points [ Time Frame: up to 4 days ]
  9. Apparent volume of distribution during the terminal phase λz following an extravascular administration (Vz/F) for several time points [ Time Frame: up to 4 days ]
  10. Amount of analyte that is eliminated in urine from zero to 24 h after drug administration (Ae0-24) for several time points [ Time Frame: up to 4 days ]
  11. Fraction of analyte eliminated in urine from zero to 24 h after drug administration (fe0-24) for several time points [ Time Frame: up to 4 days ]
  12. Renal clearance of the analyte from zero to 24 h after drug administration (CLR,0-24) for several time points [ Time Frame: up to 4 days ]
  13. Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss) [ Time Frame: up to 4 days ]
  14. Accumulation ratio (RA) based on Cmax for several time points [ Time Frame: up to 4 days ]
  15. RA based on AUC for several time points [ Time Frame: up to 4 days ]
  16. Linearity index (LI) of the analyte in plasma [ Time Frame: up to 4 days ]


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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females according to the following criteria based upon a complete medical history, including the physical examination, vital signs, 12-lead ECG, clinical laboratory tests
  • Age ≥21 and Age ≤50 year
  • 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 vital signs 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
  • Surgery of the gastrointestinal tract (except appendectomy)
  • 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 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
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Smoking (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 40 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 trial site
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  • A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)

Exclusion criteria for male subjects are:

  • Not willing to use adequate contraception (condom 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

Exclusion criteria for female subjects are:

  • Pregnancy or planning to become pregnant within 3 months of study completion
  • Positive pregnancy test
  • No adequate contraception, e.g. implants, injectables, combined oral contraceptives, surgical sterilisation (including hysterectomy or bilateral ovariectomy), intrauterine device, not having used an adequate method of contraception for at least three months prior to participation in the study, and not willing or able to use such adequate contraception until three months after the last intake of study drug
  • Lactation

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02215759    
Other Study ID Numbers: 1246.15
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014