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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01233830
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : April 12, 2011
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD2423 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Study Start Date : November 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: 1 Drug: AZD2423
oral solution
Placebo Comparator: 2 Drug: Placebo
oral solution

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01233830

Research Site
Fukuoka, Japan
Sponsors and Collaborators
Study Director: Bror Jonzon, MD, PhD AstraZeneca R&D Södertälje
Principal Investigator: Akimasa Watanabe Kyushu Clinical Pharmacology Research Clinic

Responsible Party: Medical Science Director, AstraZeneca Identifier: NCT01233830     History of Changes
Other Study ID Numbers: D2600C00004
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: April 12, 2011
Last Verified: April 2011

Keywords provided by AstraZeneca:
safety, tolerability, pharmacokinetics, AZD2423, Japanese