Adult T-cell Leukemia-Lymphoma
Conditions
Interventions
Administration of investigational drug (5- aminolevulinic acid)
10mg/kg Single-dose , Oral
Sponsors
Murakami Harumi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Subjects who signed the written informed consent 2) Male 3) Age>=20 and ==18.5 and <25.0
Exclusion criteria
Exclusion criteria: 1) History of any significant drug allergy. 2) History of drug and/or alcohol abuse 3) History of renal, hepatic, cardiovascular, metabolic, respiratory disease. 4) A positive infection test and/or urine drug screen for substance of abuse at screening. 5) Subjects having taken an following drug and/or food. - Prescription and over-the-counter drugs : within the 14 days prior to the administration of investigational drug. - The following drugs known to cause photosensitivity : within the 14 days prior to the administration of investigational drug. Tetracycline antibiotics, sulfonamides, new quinolone antibacterial agents, hypericin (Hypericum erectum extract) - Supplements containing 5-aminolevulinic acid : within the 14 days prior to the administration of investigational drug. - Foods containing St. John's Wort (St. John's Wort) : within the 14 days prior to the administration of investigational drug. - Consumption of alcohol: within the 3 days prior to the administration of investigational drug. 6) Subjects who participated in other clinical trials within 16 weeks prior to the administration of investigational drug. 7) Subjects who received 200 mL of blood (donated blood, etc.) within 4 weeks, 400 mL within 12 weeks, or 1200 mL or more within 1 year prior to the administration of investigational drug. and those who donated blood components within 2 weeks. 8) body weight : < 50 kg 9) Subjects who scheduled to visit another hospital during the clinical trial period 10) Subjects who had Clinically significant abnormality at screening phase and judged by the investigator to be unhealthy 11) Subjects who are judged by the investigator to be inappropriate for conducting this clinical study safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and Safety | — |
Contacts
Public ContactMikiko Haraguchi
Otsuka Medical Device Co., Ltd.
Outcome results
None listed