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Bioavailability of BI 44370 TA Drinking Solution or Tablets With and Without a High Fat Meal in Healthy Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT02215746
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The objective of this trial was to evaluate the relative oral bioavailability and pharmacokinetics of BI 44370 TA drinking solution (100 mg and 200 mg) and BI 44370 TA tablets (100 mg as two 50 mg tablets) with and without a high fat meal and to assess the safety and tolerability of the substances.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 44370 powder for oral solution Drug: BI 44370 tablet Other: high fat breakfast Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relative Oral Bioavailability of BI 44370 TA Drinking Solution (100 mg and 200 mg) and BI 44370 TA Tablets (100 mg as Two 50 mg Tablets) With and Without a High Fat Meal in Healthy Male and Female Volunteers: A Single Dose, Open-label, Randomised Six-way Cross-over Trial
Study Start Date : January 2008
Actual Primary Completion Date : April 2008

Arm Intervention/treatment
Experimental: Treatment A
BI 44370 TA drinking solution 100 mg fasted
Drug: BI 44370 powder for oral solution
Experimental: Treatment B
BI 44370 TA drinking solution 100 mg fed
Drug: BI 44370 powder for oral solution
Other: high fat breakfast
Experimental: Treatment C
BI 44370 TA drinking solution 200 mg fasted
Drug: BI 44370 powder for oral solution
Experimental: Treatment D
BI 44370 TA drinking solution 200 mg fed
Drug: BI 44370 powder for oral solution
Other: high fat breakfast
Experimental: Treatment E
100 mg BI 44370 BS as two tablets 50 mg fasted
Drug: BI 44370 tablet
Experimental: Treatment F
100 mg BI 44370 BS as two tablets 50 mg fed
Drug: BI 44370 tablet
Other: high fat breakfast



Primary Outcome Measures :
  1. Cmax (maximum concentration of the analyte in plasma) [ Time Frame: up to 24 hours after drug administration ]
  2. AUC0-2 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 2 h after drug administration) [ Time Frame: up to 2 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 24 hours after drug administration ]
  4. tmax (time from dosing to maximum measured concentration) [ Time Frame: up to 24 hours after drug administration ]

Secondary Outcome Measures :
  1. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: up to 24 hours after drug administration ]
  2. 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 24 hours after drug administration ]
  3. AUCt1-t2 (Area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2) [ Time Frame: up to 24 hours after drug administration ]
  4. λz (terminal rate constant in plasma) [ Time Frame: up to 24 hours after drug administration ]
  5. t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 24 hours after drug administration ]
  6. MRTp.o. (mean residence time of the analyte in the body after p.o. administration) [ Time Frame: up to 24 hours after drug administration ]
  7. CL/F (total/apparent clearance of the analyte in plasma after extravascular administration) [ Time Frame: up to 24 hours after drug administration ]
  8. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 24 hours after drug administration ]
  9. Number of patients with clinically relevant findings in vital signs (blood pressure and pulse rate) [ Time Frame: up to 11 days ]
  10. Number of patients with clinically relevant findings in 12-lead ECG (electrocardiogram) [ Time Frame: up to 11 days ]
  11. Number of patients with clinically relevant laboratory findings [ Time Frame: up to 11 days ]
  12. Number of patients with adverse events [ Time Frame: up to 34 days ]
  13. Assessment of tolerability by investigator on a 4-point scale [ Time Frame: within 10 days after administration of study drug ]


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects 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
  • Age ≥21 and ≤55 years
  • BMI ≥18.5 and ≤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 BP, PR, 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
  • Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 60 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, hypokalemia, family, history of Long QT Syndrome)

For Male Subjects:

  • Not willing to use adequate contraception (condoms 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

For Female Subjects:

  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception (adequate contraception e.g. sterilisation, intrauterine pessary (IUP), oral contraceptives)
  • Inability to maintain this adequate contraception during the whole study period during the whole study period from the time of the first intake of study drug until one month after the last intake
  • Lactation period

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02215746    
Other Study ID Numbers: 1246.2
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