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Completed

NCT Number: NCT00912353

AZD7268 Single Ascending Dose Study in Healthy Japanese Subjects

This is a Phase I, single center, randomized, double-blind, placebo-controlled single ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268 in healthy Japanese subjects.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Gelndale, California, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Japanese male and female (of non-child bearing potential) subjects 20 to 45 years of age, inclusive
  • Body weight between 50 and 90 kg, inclusive, with a Body Mass Index (BMI)
  • 18 to ≤ 27 kg/m2

Exclusion criteria

  • Clinically relevant disease or disorder (past or present), 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 significant abnormalities in physical examination, vital signs, clinical chemistry, hematology or urinalysis results as judged by the investigator and/or sponsor
  • Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1

Treatment and study plan

AZD7268

Drug

Single Oral

Placebo

Drug

Single Oral

Primary outcomes

  1. To asses the safety nature and incidence of adverse events, blood pressure, pulse rate, body temperature, physical examination, laboratory assessments (clinical chemistry, hematology, and urinalysis parameters), effects on ECG parameters, EEG recordings,

    Time frame: From screening period to follow-up, 44 days (maiximum).

Secondary outcomes

  1. To characterize the pharmacokinetics of AZD7268 and its metabolite(s) in plasma and urine.

    Time frame: Blood and urine sampling from pre-dose until 72 hrs 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 Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 in Healthy Japanese Subjects

Acronym: JSAD

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 3, 2009
Registry last updated
Jan 29, 2013

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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