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AZD2423 Single Ascending Dose Study in Healthy Japanese Subjects (JSAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00970775
First received: September 1, 2009
Last updated: March 17, 2010
Last verified: March 2010
  Purpose

This is a Phase I, single centre, randomised, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability and pharmacokinetics of AZD2423 following single ascending dose administration to healthy Japanese subjects.


Condition Intervention Phase
Healthy Volunteer
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, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 After Single Ascending Doses in Healthy Japanese Male and Non-Fertile Female Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables. [ Time Frame: From screening period to follow-up visit, 40 days (Maximum). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetics of AZD2423 in plasma and urine. [ Time Frame: Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately) ] [ Designated as safety issue: No ]
  • Exploratory endpoints;Levels of CCL2 pre-and post dose [ Time Frame: Blood sampling after dosing, 3 days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: August 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. AZD2423 Drug: AZD2423
oral solution, single dose
Placebo Comparator: 2. Placebo Drug: Placebo
oral solution,single dose

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese male and non-fertile female subjects aged ≥20 to ≤55 years with suitable veins for cannulation or repeated venepuncture.
  • Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2
  • Clinically normal physical findings including supine blood pressure, pulse rate, orthostatic blood pressure, ECG, and laboratory assessments in relation to age, as judged by the Investigator.

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
  • Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 3 months of the first administration of investigational product.
  • Frequent use of tobacco or other nicotine containing products. Frequent use is defined as smoking or consumption/intake of nicotine products more than two days per week during the last 12 weeks.
  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: NCT00970775

Locations
United Kingdom
Research Site
Croydon, United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Ulrike Lorch, MD MFPM FRCA Richmond Pharmacology Limited
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00970775     History of Changes
Other Study ID Numbers: D2600C00003
Study First Received: September 1, 2009
Last Updated: March 17, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Phase I
Japanese healthy volunteer
AZD2423

ClinicalTrials.gov processed this record on November 24, 2014