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Completed

NCT Number: NCT01415791

Oral Mucosal Absorption of ICI176,334-1

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

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICI176,334-1

Drug

Subject will receive single dose of ICI176,334-1

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Oral Mucosal Absorption of ICI176,334-1 in Japanese Healthy Male Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 12, 2011
Registry last updated
May 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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