Oral Mucosal Absorption of ICI176,334-1

NCT01415791 | Completed Phase 1

• 1 other identifier: D6874L00026
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

oral mucosal absorption; pharmacokinetics; safety; bicalutamide; Japanese; healthy subject

Outcome Measures

Primary Outcomes (4)

• 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 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

  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 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

  Samples are taken at 168 hours after application of the investigational drug

Secondary Outcomes (3)

• 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

Study Arms (1)

Active 1

EXPERIMENTAL

8 subjects will receive ICI176,334-1

Drug: ICI176,334-1

Interventions

ICI176,334-1 DRUG

Subject will receive single dose of ICI176,334-1

Active 1

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 12, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 30, 2012

Record last verified: 2012-05