Chronic myelogenous leukemia
Conditions
Interventions
TM5614 (60, 120mg,once a day for 7 days)
Placebo (once a day for 7 days)
Sponsors
Tohoku university school of medicine, molecular medicine and therapy
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male Japanese 2. From 20 years old to 45 years old at voluntary written consent 3. From 50.0 kg to 85.0 kg and from 18.5 to 25.0 of BMI at screening 4. Voluntary written consent by themselves is given before screening
Exclusion criteria
Exclusion criteria: 1. Male Japanese 2. From 20 years old to 45 years old at voluntary written consent 3. From 50.0 kg to 85.0 kg and from 18.5 to 25.0 of BMI at screening 4. Voluntary written consent by themselves is given before screening. 1. History of liver diseases, cardiovascular diseases, respiratory diseaases, gastroenteric diseases, kidney diseases, cerebralvascular diseases, cancer 2. Known hypersensitivity to some drugs and foods 3. Treatment by other doctors (included supplement) within 14 days before screening 4. Treatment with any investigational compound within 120 days before screening 5. History of TM5614 administration 6. History of blood taken *>= 1200ml of all blood within 1 year before screening *>= 400ml of all blood with 84 days before screening *>= 200ml of all blood within 14 days before screening 7. Smoking status and treatment with anti-nicotine agents 8. Known active chronic hepatitis B or C, active syphilis and human immunodeficiency virus infection 9. Abuse of alcohol or drugs (included past history) 10. Bleeding, in the tendency to bleeding, and family history and past history of bleeding disorders 11. Somebody who are directed by principle investigator and employees in Hamamatsu University hospital 12. Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of TM5614(until 7 days after the last administration) Vital sign, Electrocardiogram Laboratory examination Adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and pharmacodynamics of TM5614 (until 96 hours after the administration) | — |
Countries
Japan
Contacts
Public ContactKazuo Umemura
Hamamatsu University Hospital Center for clinical research
Outcome results
None listed