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Completed

NCT Number: NCT01233830

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

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

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AZD2423

Drug

oral solution

Placebo

Drug

oral solution

Primary outcomes

  1. Number of participants with Adverse events

    Time frame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)

  2. Vital signs

    Time frame: 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

  3. Electrocardiograms

    Time frame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)

  4. Laboratory Variables (hematology, urinalysis and clinical chemistry)

    Time frame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)

Secondary outcomes

  1. Plasma concentration over time

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 3, 2010
Registry last updated
Apr 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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