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Completed

NCT Number: NCT00970775

AZD2423 Single Ascending Dose Study in Healthy Japanese Subjects

This is a Phase I, single centre, randomised, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability and pharmacokinetics of AZD2423 following single ascending dose administration to healthy Japanese subjects.

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Key information

Conditions

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Croydon, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Japanese male and non-fertile female subjects aged ≥20 to ≤55 years with suitable veins for cannulation or repeated venepuncture.
  • Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2
  • Clinically normal physical findings including supine blood pressure, pulse rate, orthostatic blood pressure, ECG, and laboratory assessments in relation to age, as judged by the Investigator.

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 significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 3 months of the first administration of investigational product.
  • Frequent use of tobacco or other nicotine containing products. Frequent use is defined as smoking or consumption/intake of nicotine products more than two days per week during the last 12 weeks.

Treatment and study plan

AZD2423

Drug

oral solution, single dose

Placebo

Drug

oral solution,single dose

Primary outcomes

  1. To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables.

    Time frame: From screening period to follow-up visit, 40 days (Maximum).

Secondary outcomes

  1. To characterize the pharmacokinetics of AZD2423 in plasma and urine.

    Time frame: Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately)

  2. Exploratory endpoints;Levels of CCL2 pre-and post dose

    Time frame: Blood sampling after dosing, 3 days

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 After Single Ascending Doses in Healthy Japanese Male and Non-Fertile Female Volunteers

Acronym: JSAD

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 2, 2009
Registry last updated
Mar 18, 2010

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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