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

A Phase I, Single Centre, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 Solution After Administration of Multiple Ascending Doses for 12 Days in Young and Elderly Healthy Japanese Volunteers

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: AZD2423

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD2423; oral solution
Placebo Comparator: 2	Drug: Placebo; oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse events		Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Vital signs	Changes from baseline in systolic blood pressure, pulse rate and body temperature	Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Bror Jonzon, MD, PhD, AstraZeneca R&D Södertälje; Principal Investigator: Akimasa Watanabe, Kyushu Clinical Pharmacology Research Clinic

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: October 19, 2010
• First Submitted That Met QC Criteria: November 2, 2010
• First Posted (Estimate): November 3, 2010

Study Record Updates

• Last Update Posted (Estimate): April 12, 2011
• Last Update Submitted That Met QC Criteria: April 11, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: safety, tolerability, pharmacokinetics, AZD2423, Japanese
• Other Study ID Numbers: D2600C00004