AZD2423 Single Ascending Dose Study in Healthy Japanese Subjects

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: AZD2423; Drug: Placebo

• Registration Number: NCT00970775
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-17
• Last Update Posted: 2010-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. AZD2423	AZD2423	-
2. Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables.	From screening period to follow-up visit, 40 days (Maximum).

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom