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Completed

NCT Number: NCT00904800

AZD0837 Extended Release (ER) Japan Study

This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Kagoshima, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male Japanese subject aged between 20 to 45 years inclusive

Exclusion criteria

  • Acute illness (including ongoing or history of liver disease), trauma or surgical procedures within two weeks before Visit 1 or pre first dose in Visit 2
  • Intake of another investigational drug within 4 months before Visit 1 or pre first dose in Visit 2
  • Blood donation and/or sampling in excess of 200 mL of whole blood within the preceding 4 weeks, 400 mL of whole blood within the preceding 12 weeks and/or 1200 mL of whole blood within the preceding 12 months, before Visit 1 or pre first dose in Visit 2

Treatment and study plan

AZD0837

Drug

tablet, oral, once daily, 1+5 days

Placebo

Drug

Placebo

Primary outcomes

  1. To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects.

    Time frame: All assessments are made at each visit, at least daily, during the study.

Secondary outcomes

  1. To investigate the pharmacokinetics (PK) of AZD0837, AR H069927XX and AR-H067637XX after single and repeated oral dosing of AZD0837 ER tablet, in Japanese healthy subjects.

    Time frame: Blood samples will be taken before and after study drug administration.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Single-blind, Randomised, Placebo-controlled, Parallel-group, Single Centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended-release Tablets AZD0837 After Single and Repeated Oral Administration to Young Healthy Male Japanese Subjects

Acronym: ER J ph I

Important dates

Study start
2009
Study completion
2009
First posted
May 20, 2009
Registry last updated
Jul 13, 2009

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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