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

AstraZeneca1 site in 1 country32 target enrollmentAugust 2009

ConditionsHealthy Volunteer

InterventionsAZD2423 Placebo

DrugsAZD2423 Placebo

Overview

Phase: Phase 1
Intervention: AZD2423
Conditions: Healthy Volunteer
Sponsor: AstraZeneca
Enrollment: 32
Locations: 1
Primary Endpoint: To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

December 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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.

Arms & Interventions

1. AZD2423

Intervention: AZD2423

2. Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

To characterize the pharmacokinetics of AZD2423 in plasma and urine.(Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately))
Exploratory endpoints;Levels of CCL2 pre-and post dose(Blood sampling after dosing, 3 days)