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

NCT00977626 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2012-01-23

No results posted yet for this study

Summary

Three-part study investigating the safety and tolerability of AZD2423 multiple doses in 98 healthy volunteers: Part 1 80 young and elderly subjects in a parallel, double blind, randomised study. Part 2 - 6 subjects in an open, non-randomised study. Part 3 - 12 subjects in a three-way cross over, open label, partially randomised study.

Part 1 has 2 Arms, AZD2423 or Placebo, Multiple dosing during 10-14 days . Part 2 has 1 Arm AZD2423 Multiple dosing and Part 3 has 3 Arms AZD2423 single dosing or AZD2423 single dosing with food or AZD2423 single dosing, Fasting Condition

Conditions

  • Healthy

Interventions

DRUG

Part 1 - AZD2423 or Placebo

AZD2423 Oral Solution, multiple dosing during 10-14 days or Placebo Oral Solution, multiple dosing during 10-14 days

DRUG

Part 2 - AZD2423

AZD2423 Oral solution, multiple dosing

DRUG

Part 3 - AZD2423

AZD2423 Oral solution, single dosing or AZD2423 Oral solution, single dosing - With Food or AZD2423 Oral solution, single dosing - Fasting Condition.

Sponsors & Collaborators

Principal Investigators

  • Dr Muna Albayaty · PAREXEL Early Phase Clinical Uniit, London

  • Richard Malamut · AstraZeneca R&D

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00977626 on ClinicalTrials.gov