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OpenTrials
Completed

NCT Number: NCT00738959

Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese

This study will be performed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male volunteers.

Completed

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Key information

Conditions

Healthy Volunteers

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

  • first generation Japanese (both parents and grandparents are Japanese, the subject is born in Japan and left Japan less than 10 years ago) or Caucasian subjects.
  • Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.

Exclusion criteria

  • History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the study.
  • Participation in another study within 12 weeks before the first administration of the investigational product.
  • Intake of any prescribed medicine or herbal remedies based on St John's Wort, except for occasional paracetamol and nasal adrenergic anticongestants, within 3 weeks before the first administration of the investigational product.

Treatment and study plan

AZD0328

Drug

Oral solution A single dose Day 1 followed by once daily doses on Day 3-7

Primary outcomes

  1. Safety variables (adverse events, vital signs, paper ECGs and 12-lead continuous digital ECGs including QT/QTc interval measurements

    Time frame: During the whole treatment period

Secondary outcomes

  1. PK variables

    Time frame: Several samples during the study days

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0328 in Healthy Young Japanese and Caucasian Male Volunteers After Oral Single and Multiple Ascending Doses

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 21, 2008
Registry last updated
Oct 29, 2008

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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