The breast cancer metastasized to the brain
Conditions
Interventions
Cassette-dosing study drug (Cetrozole and TMD-322)
Anastrozole
Sponsors
Osaka City University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy male volunteers who are equal or more than 20-year-old and less than 40 year-old when informed consent is obtained 2) Body mass index (BMI) is between 18.0 and 30.0 3) Volunteers enable to agree to make contraception during the study and one month after the final dosing of study drugs 4) A written informed consent is obtained by volunteers after being informed of this study, which is perfomed before the enrollment.
Exclusion criteria
Exclusion criteria: 1) Volunteers who have present and/or past history of disease of heart and circulatory system, liver, kidney and ureteral system, digestive system, and blood system 2) Volunteers who have present and/or past history of drug and alcohol addiction and drug allergy 3) Volunteers who is taking medicines which will affect the result of this study 4) Volunteers who had any medicines within 7 days before taking study drugs 5) Volunteers who takes health food product like St.John's wort and/or fruit juice including grape fruit juice within 7 days before taking study drugs 6) Volunteers who joined other clinical study within 3 months before this study 7) Volunteers who donated blood before this study such as: (a) >200 mL within a month (b) >400 mL within 3 months 8) Volunteers who is positive for serological reaction of syphilis, HIV antibody, HBs antigen, HCV antibody 9) Others: Volunteers who are diagnosed by medical doctors as unsuitable for joining this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma pharmacokinetics of Cetrozole, TMD-322 and anastrozole | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Japan
Contacts
Public ContactHisako Fujii
Osaka City University Hospital Center for Drug & Food Clinical Evaluation
Outcome results
None listed