healthy male subjects
Conditions
Interventions
wild-wild Group1: 3days iv 100microgram
wild-mutation Group2: 3days iv 100microgram
mutation-mutation Group3: 3days iv 100microgram
Sponsors
Clinical trial Center, Kitasato University East Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Ability to understand and willing to sign the informed consent. 2) Japanese healthy male subjects age 20 to 40 years of age 3) Body Mass Index (BMI):18.5~28.5 4) good health as determined by physical examination, vital signs and laboratory tests.
Exclusion criteria
Exclusion criteria: 1) any medical condition that requires medical attention 2) impairments of liver or kidney functions 3) hepatic disease and history of this disease 4)Any hypersensitivitiies to BSP (bromosulfophthalein) 5)Use of medicine or health product including Saint John's wort 2 weeks before pre-dose 6) Participation to any other clinical research in the past 3 months. 7) Donating over 200 ml of blood in the past 1 month or over 400ml of blood in the past 3 months. 8) Positive tests of serological reaction for syphilis, HIV antigen and antibody, HBs antigen or HCV antibody. 9) Any allergy to drug and food 10) history of drug or alcohol abuse screening 11) Any condition that, in the opinion of the investigator, would make the patient unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gene analysis | — |
Countries
Japan
Outcome results
None listed