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Oral Mucosal Absorption Study of Bicalutamide New Formulation

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ClinicalTrials.gov Identifier: NCT01416883
Recruitment Status : Terminated
First Posted : August 15, 2011
Last Update Posted : August 15, 2011
Sponsor:
Information provided by:

Study Description
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

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

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

Study Design

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 Study of ICI176,334-1 (Bicalutamide New Formulation) in Japanese Healthy Male Subjects
Study Start Date : July 2010
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 saliva. [ Time Frame: Blood samples are taken repeatedly for 72 hours and also taken at 168 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: Blood samples are taken repeatedly for 72 hours and also 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: 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. ]
  2. To assess the safety by assessment of vital signs. [ Time Frame: 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. ]
  3. To assess the safety by assessment of electrocardiograms (ECGs). [ Time Frame: 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. ]

Eligibility Criteria

Information from the National Library of Medicine

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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
More Information

Responsible Party: Gerard Lynch, AstraZeneca
ClinicalTrials.gov Identifier: NCT01416883     History of Changes
Other Study ID Numbers: D6874L00016
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: August 15, 2011
Last Verified: August 2011

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