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Oral Mucosal Absorption Study of Bicalutamide New Formulation

This study has been terminated.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01416883
First received: August 12, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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 Intervention Phase
Healthy
 Drug: ICI176,334-1
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Mucosal Absorption Study of ICI176,334-1 (Bicalutamide New Formulation) in Japanese Healthy Male Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active 1
8 subjects will receive ICI176,334-1
 Drug: ICI176,334-1
Subject will receive single dose of ICI176,334-1

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Gerard Lynch, AstraZeneca
ClinicalTrials.gov Identifier: NCT01416883     History of Changes
Other Study ID Numbers: D6874L00016
Study First Received: August 12, 2011
Last Updated: August 12, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013