Oral Mucosal Absorption Study of Bicalutamide New Formulation

Study Overview
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Brief Summary
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The purpose of this study is to investigate the presence or absence of oral mucosal absorption of bicalutamide after ICI176,334.1 is given to Japanese healthy male subjects

Detailed Description
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Oral mucosal absorption study of ICI176,334-1 (Bicalutamide new formulation) in Japanese healthy male subjects

Official Title
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Oral Mucosal Absorption Study of ICI176,334-1 (Bicalutamide New Formulation) in Japanese Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: ICI176,334-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated, written informed consent prior to any study specific procedures Japanese healthy male subjects aged 20 to 45 years Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational product Have a body mass index (BMI) between 17 and 27 kg/m2 Eligible based on the physical findings, supine BP, pulse rate, ECG and laboratory assessments, as judged by the investigator(s) Exclusion Criteria: Presence of any disease under medical treatment History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, immunological, blood, endocrine, neurological or mental disease to interfere with absorption, distribution, metabolism or excretion of drugs judged by investigator(s) Presence of any infectious disease, such as bacteria, virus and fungus Presence of allergic disorder, such as asthma, pollen disease or atopic dermatitis, and judged as necessary any medical treatment Any large surgical history of gastrointestinal tract such as gastric/intestinal resection or suturation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active 1<br>8 subjects will receive ICI176,334-1 | Drug: ICI176,334-1<br>* Subject will receive single dose of ICI176,334-1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 saliva. |  | Blood samples are taken repeatedly for 72 hours and also 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 plasma. |  | Blood samples are taken repeatedly for 72 hours and also taken at 168 hours after application of the investigational drug. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety by assessment of adverse event. |  | Subjects will be monitored for adverse events prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug. | 
| To assess the safety by assessment of vital signs. |  | Subjects will be monitored for vital signs prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug. | 
| To assess the safety by assessment of electrocardiograms (ECGs). |  | Subjects will be monitored for electrocardiograms (ECGs) prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral mucosal absorption, pharmacokinetics, safety, bicalutamide, Japanese, healthy subject