Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 Multiple Doses in Healthy Japanese Volunteers

Phase 1

Completed

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

• Registration Number: NCT01233830
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD2423 in young and elderly healthy Japanese volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-19
• Study Start: 2010-11
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-11
• Last Update Posted: 2011-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures
• Healthy Japanese male volunteers aged ≥20 to ≤45 years and healthy Japanese male and female volunteers aged ≥65 to ≤80 years with suitable veins for cannulation or repeated venipuncture
• Have a body mass index (BMI) between ≥17 and ≤27 kg/m2, as calculated by the investigator(s), and weigh at least 45 kg and no more than 100 kg
• Clinically normal physical findings including supine blood pressure, pulse rate, ECG, and laboratory assessments in relation to age, as judged by the investigator(s)

Exclusion Criteria

• History of any clinically significant disease or disorder which, in the opinion of the investigator(s), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
• Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the investigator(s), within 3 months of the first administration of investigational product or known malignancy within the past 5 years (with the exception of successfully treated basal cell carcinoma)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	AZD2423	-

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse events	Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Vital signs	Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)	Changes from baseline in systolic blood pressure, pulse rate and body temperature
Electrocardiograms	Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Laboratory Variables (hematology, urinalysis and clinical chemistry)	Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)

Secondary Outcome Measures

Name	Time	Method
Plasma concentration over time	Pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours after the first dose

Trial Locations

Locations (1)

Research Site; 🇯🇵 Fukuoka, Japan