UMIN ID: UMIN000007025
Registered date:06/01/2012
A clinical cassette microdose study of aromatase inhibitors
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | The breast cancer metastasized to the brain |
| Date of first enrollment | 2012/01/01 |
| Target sample size | 6 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Cassette-dosing study drug (Cetrozole and TMD-322) Anastrozole |
Outcome(s)
| Primary Outcome | Plasma pharmacokinetics of Cetrozole, TMD-322 and anastrozole |
|---|---|
| Secondary Outcome | Safety |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 40years-old |
| Gender | Male |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Osaka City University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | New Energy and Industrial Technology Development Organization (NEDO) |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hisako Fujii |
| Address | Japan |
| Telephone | 06-6645-3443 |
| hfujii@med.osaka-cu.ac.jp | |
| Affiliation | Osaka City University Hospital Center for Drug & Food Clinical Evaluation |
| scientific contact | |
| Name | Tsutomu Takashima |
| Address | 1-5-7 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan Japan |
| Telephone | |
| Affiliation | Osaka City University Hospital Department of Surgical Oncology |