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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Subject will receive single dose of ICI176,334-1
To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in plasma
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Samples are taken at 168 hours after application of the investigational drug
To assess the safety by assessment of adverse event
Time frame: 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
Time frame: Collect prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug
To evaluate the safety by assessment of electrocardiograms (ECGs)
Time frame: Collect prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug
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