pilot study of micro dose
Conditions
Interventions
1:single-dose 4mg Imatinib Mesylate (Gleevec)
Sponsors
Beijing Shijitan Hospital Capital Medical University
Eligibility
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese males and females 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; 2. Age 18 to 40 years; 3. BMI 19 to 24 kg/m2 (incl.), body weight more than 50kg; 4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Exclusion criteria
Exclusion criteria: 1. Any finding of the medical examination (including BP, PR 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. 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. 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) or Drug abuse; 14. Blood donation (more than 100 mL within four weeks prior to administration or during the trial); 15. Excessive physical activities (within one week prior to administration or during the trial); 16. Any laboratory value outside the reference range that is of clinical relevance; 17. Inability to comply with dietary regimen of trial site; 18. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval more than 450 ms); 19. A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome); 20. Positive pregnancy test, pregnancy, or planning to become pregnant during the six month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure;Pulse;ECG; | — |
Countries
China
Contacts
Public ContactXinghe Wang
Outcome results
None listed