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Completed

NCT Number: NCT00886756

AZD8529 Single Ascending Dose Study in Healthy Japanese Subjects

This is a Phase I, double-blind, placebo-controlled, randomised within each dose group, single ascending dose study, with the objective to assess the safety, tolerability and pharmacokinetic profile of AZD8529 in healthy Japanese subjects.

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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

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male Japanese subjects aged 20 to 45 years (inclusive)
  • Have a body mass index (BMI) between 18 and 27 kg/m 2 (inclusive) and weigh at least 50 kg.least 50 kg.

Exclusion criteria

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
  • Any clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, haematology or urinalysis as judged by the Investigator and/or Sponsor.
  • Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1.

Treatment and study plan

AZD8529

Drug

Oral

Placebo

Drug

Oral

Primary outcomes

  1. To asses the safety:Adverse events, vital signs, physical examinations, telemetry, dECGs, clinical chemistry and haematology labs including testosterone, prolactin, LH, FSH and TSH, and urinalysis.

    Time frame: From screening period to follow-up, 42 days (maiximum).

Secondary outcomes

  1. To characterize the pharmacokinetics of AZD8529 in plasma and urine.

    Time frame: Blood and urine sampling from pre-dose until 12 days post dose.

  2. To collect and store DNA for future exploratory research

    Time frame: One blood sampling after randomisation.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Single-Centre, Randomised, Double-Blind, Placebo Controlled Single-Ascending Dose, Study to Assess the Safety, Tolerability, Pharmacokinetics of AZD8529 in Healthy Male Japanese Subjects

Acronym: JSAD

Important dates

Study start
2009
Study completion
2009
First posted
Apr 23, 2009
Registry last updated
Aug 19, 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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