Oral Mucosal Absorption Study of Bicalutamide New Formulation

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: ICI176,334-1

• Registration Number: NCT01416883
• Lead Sponsor: AstraZeneca

Brief Summary

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

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

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-08
• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-12
• Last Update Submitted: 2011-08-12
• Study First Posted: 2011-08-15
• Last Update Posted: 2011-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active 1	ICI176,334-1	8 subjects will receive ICI176,334-1

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.