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

NCT01233830 | Completed Phase 1

• 1 other identifier: D2600C00004
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

safety, tolerability, pharmacokinetics, AZD2423, Japanese

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD2423

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD2423 DRUG

oral solution

1

Placebo DRUG

oral solution

2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Fukuoka, Japan

Location

Study Officials

• Bror Jonzon, MD, PhD

  AstraZeneca R&D Södertälje

  STUDY DIRECTOR

• Akimasa Watanabe

  Kyushu Clinical Pharmacology Research Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: November 3, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 12, 2011

Record last verified: 2011-04

Locations

JP (1)