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The purpose of this study is to investigate the presence or absence of oral mucosal absorption of ICI176,334-1
Oral mucosal absorption of ICI176,334-1 in Japanese healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active 1 | Experimental | 8 subjects will receive ICI176,334-1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICI176,334-1 | Drug | Subject will receive single dose of ICI176,334-1 |
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| Measure | Description | Time Frame |
|---|---|---|
| To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in plasma | Samples are taken at 72 hours after application of the investigational drug | |
| To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in plasma | Samples are taken at 168 hours after application of the investigational drug | |
| To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in saliva | Samples are taken at 72 hours after application of the investigational drug | |
| To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in saliva | Samples are taken at 168 hours after application of the investigational drug |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety by assessment of adverse event | Adverse Events will be captured starting from screening up to 14 to 21 days (follow-up) | |
| To evaluate the safety by evaluation of vital signs | Collect prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug |
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Inclusion Criteria:
Exclusion Criteria:
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| To evaluate the safety by assessment of electrocardiograms (ECGs) | Collect prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug |