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

Overview

The primary aim of this study is to investigate the safety and tolerability of AZD2423 single doses in healthy volunteers.

Full Title of Study: “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 Male and Female Volunteers Without Childbearing Potential”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2009

Interventions

  • Drug: AZD2423
    • oral, single administration
  • Drug: Placebo
    • oral administration and single dose

Arms, Groups and Cohorts

  • Experimental: A
    • AZD2423
  • Experimental: B
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • To assess the safety and tolerability of AZD2423 following administration of single ascending doses and if possible to estimate the maximum tolerated dose (MTD), if within the predefined exposure limits.
    • Time Frame: 3 day residential period plus 7-10 days follow up

Secondary Measures

  • To characterise the pharmacokinetics of AZD2423 and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses ofAZD2423.
    • Time Frame: 3 day residential period plus 7-10 days follow up

Participating in This Clinical Trial

Inclusion Criteria

  • Provision of signed and dated, written informed consent prior to any study specific procedures – Have a body mass index (BMI) between ≥18 and ≤30 kg/m2, as calculated by the investigator, and weigh at least 50 kg and no more than 100 kg – Healthy male and non-fertile female volunteers with suitable veins for cannulation or repeated venipuncture 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 – 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 Principal Investigator, within 3 months of the first administration of investigational product

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Anders Neijber, Medical Science Director, AstraZeneca
  • Overall Official(s)
    • Rainard Fuhr, MD, Principal Investigator, PAREXEL Early Phase Clinical Uniit, Berlin Germany
    • Anders Neijber, Study Director, AstraZeneca R&D Södertälje

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