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Oral Mucosal Absorption of ICI176,334-1

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ClinicalTrials.gov Identifier: NCT01415791
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : May 30, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Healthy Drug: ICI176,334-1 Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Mucosal Absorption of ICI176,334-1 in Japanese Healthy Male Subjects
Study Start Date : August 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

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



Primary Outcome Measures :
  1. To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in plasma [ Time Frame: Samples are taken at 72 hours after application of the investigational drug ]
  2. To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in plasma [ Time Frame: Samples are taken at 168 hours after application of the investigational drug ]
  3. To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in saliva [ Time Frame: Samples are taken at 72 hours after application of the investigational drug ]
  4. To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in saliva [ Time Frame: Samples are taken at 168 hours after application of the investigational drug ]

Secondary Outcome Measures :
  1. To assess the safety by assessment of adverse event [ Time Frame: Adverse Events will be captured starting from screening up to 14 to 21 days (follow-up) ]
  2. To evaluate the safety by evaluation of vital signs [ Time Frame: Collect prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug ]
  3. To evaluate the safety by assessment of electrocardiograms (ECGs) [ Time Frame: Collect prior to treatment and up to 14 to 21 days (follow-up) after application of the investigational drug ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01415791     History of Changes
Other Study ID Numbers: D6874L00026
First Posted: August 12, 2011    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by AstraZeneca:
oral mucosal absorption
pharmacokinetics
safety
bicalutamide
Japanese
healthy subject

Additional relevant MeSH terms:
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents