Oral Mucosal Absorption Study of Bicalutamide New Formulation

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

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

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: ICI176,334-1

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active 1; 8 subjects will receive ICI176,334-1	Drug: ICI176,334-1; Subject will receive single dose of ICI176,334-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: August 12, 2011
• First Submitted That Met QC Criteria: August 12, 2011
• First Posted (Estimate): August 15, 2011

Study Record Updates

• Last Update Posted (Estimate): August 15, 2011
• Last Update Submitted That Met QC Criteria: August 12, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: safety; bicalutamide; pharmacokinetics; Japanese; healthy subject; oral mucosal absorption
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Androgen Antagonists; Bicalutamide
• Other Study ID Numbers: D6874L00016