Oral Mucosal Absorption of ICI176,334-1

Phase 1

Completed

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

• Registration Number: NCT01415791
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to investigate the presence or absence of oral mucosal absorption of ICI176,334-1

Detailed Description

Oral mucosal absorption of ICI176,334-1 in Japanese healthy male subjects

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-29
• Last Update Posted: 2012-05-30

Recruitment & Eligibility

• Status: COMPLETED
• 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 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 168 hours after application of the investigational drug

Secondary Outcome Measures

Name	Time	Method
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
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