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Bioequivalence of ICI176,334-1 in Japanese Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01415778
First received: August 11, 2011
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese healthy male subjects.


Condition Intervention Phase
Healthy
 Drug: ICI176,334-1
Drug: Casodex 80 mg tablet
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioequivalence Study of ICI176,334-1 in Japanese Healthy Male Subjects - Evaluation of Bioequivalence of ICI176,334-1 and Casodex 80 mg Tablet -

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To investigate the bioequivalence of ICI176,334-1 by assessment of maximum plasma concentration (Cmax) [ Time Frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period ] [ Designated as safety issue: No ]
  • To investigate the bioequivalence of ICI176,334-1 by assessment of time to Cmax (tmax) [ Time Frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period ] [ Designated as safety issue: No ]
  • To investigate the bioequivalence of ICI176,334-1 by assessment of area under the plasma concentration curve (AUC) [ Time Frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period ] [ Designated as safety issue: No ]
  • To investigate the bioequivalence of ICI176,334-1 by assessment of t1/2 of bicalutamide [ Time Frame: Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety by assessment of adverse event [ Time Frame: Screening day up to 35 to 42 days (follow-up) ] [ Designated as safety issue: Yes ]
  • To assess the safety by assessment of vital signs [ Time Frame: Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose. ] [ Designated as safety issue: Yes ]
  • To assess the safety by assessment of electrocardiograms (ECGs) [ Time Frame: Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose. ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active 1
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
 Drug: ICI176,334-1
Subject will receive single dose of ICI176,334-1
Drug: Casodex 80 mg tablet
Subject will receive single dose of Casodex 80 mg tablet
Experimental: Active 2
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
 Drug: ICI176,334-1
Subject will receive single dose of ICI176,334-1
Drug: Casodex 80 mg tablet
Subject will receive single dose of Casodex 80 mg tablet
Experimental: Active 3
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
 Drug: ICI176,334-1
Subject will receive single dose of ICI176,334-1
Drug: Casodex 80 mg tablet
Subject will receive single dose of Casodex 80 mg tablet
Experimental: Active 4
12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
 Drug: ICI176,334-1
Subject will receive single dose of ICI176,334-1
Drug: Casodex 80 mg tablet
Subject will receive single dose of Casodex 80 mg tablet

Detailed Description:

Bioequivalence study of ICI176,334-1 in Japanese healthy male subjects - evaluation of bioequivalence of ICI176,334-1 and Casodex 80 mg tablet -

  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: AstraZeneca
ClinicalTrials.gov Identifier: NCT01415778     History of Changes
Other Study ID Numbers: D6874L00025
Study First Received: August 11, 2011
Last Updated: May 29, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
Bioequivalence
pharmacokinetics
safety
bicalutamide
 Casodex
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 June 18, 2013