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

August 12, 2011
August 12, 2011
July 2010
August 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Oral Mucosal Absorption Study of Bicalutamide New Formulation
Oral Mucosal Absorption Study of ICI176,334-1 (Bicalutamide New Formulation) in Japanese Healthy Male Subjects

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

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

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: ICI176,334-1
Subject will receive single dose of ICI176,334-1
Experimental: Active 1
8 subjects will receive ICI176,334-1
Intervention: Drug: ICI176,334-1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01416883
D6874L00016
Not Provided
Gerard Lynch, AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP