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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01233830
First received: October 19, 2010
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: AZD2423
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of participants with Adverse events [ Time Frame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3) ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3) ] [ Designated as safety issue: Yes ]
    Changes from baseline in systolic blood pressure, pulse rate and body temperature

  • Electrocardiograms [ Time Frame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3) ] [ Designated as safety issue: Yes ]
  • Laboratory Variables (hematology, urinalysis and clinical chemistry) [ Time Frame: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD2423
oral solution
Placebo Comparator: 2 Drug: Placebo
oral solution

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233830

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

No publications provided

Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01233830     History of Changes
Other Study ID Numbers: D2600C00004
Study First Received: October 19, 2010
Last Updated: April 11, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on October 01, 2014