Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113823 Powder in Bottle (PiB) and Tablet in Healthy Male Volunteers
NCT ID: NCT02259972
Last Updated: 2014-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
63 participants
INTERVENTIONAL
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BI 113823 solution
single rising doses, dose group 5 twice (fed and fasted)
BI 113823 solution
High fat, high calorie breakfast
only for dose group 5
BI 113823 tablet
dose group 5 only
BI 113823 tablet
High fat, high calorie breakfast
only for dose group 5
Placebo
Placebo
Interventions
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BI 113823 solution
BI 113823 tablet
Placebo
High fat, high calorie breakfast
only for dose group 5
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
45 Years
MALE
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Other Identifiers
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1272.1
Identifier Type: -
Identifier Source: org_study_id
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