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CompletedNCT00970775JSADUpdated Mar 18, 2010

AZD2423 Single Ascending Dose Study in Healthy Japanese Subjects

A Phase 1 interventional study of AZD2423 and Placebo in Healthy Volunteer, sponsored by AstraZeneca. Completed at 2 sites in United Kingdom. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-18.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Volunteer

Keywords

  • Phase I
  • Japanese healthy volunteer
  • AZD2423
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    1. AZD2423

    Drug: AZD2423

  • Placebo comparator
    2. Placebo

    Drug: Placebo

Interventions

  • DrugAZD2423

    oral solution, single dose

  • DrugPlacebo

    oral solution,single dose

06

What researchers measure

Primary outcomes

  1. To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables.

    Time frame: From screening period to follow-up visit, 40 days (Maximum).

Secondary outcomes

  1. 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)

  2. Exploratory endpoints;Levels of CCL2 pre-and post dose

    Time frame: Blood sampling after dosing, 3 days

07

Study locations

2 sites
  • Research Site
    Croydon, United Kingdom
  • Research Site
    London, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00970775
Lead sponsor
AstraZeneca
First posted
Sep 2, 2009
Start date
Aug 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Mar 18, 2010

Study contacts

Ulrike Lorch, MD MFPM FRCA
principal investigator · Richmond Pharmacology Limited

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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