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

AstraZeneca1 site in 1 country80 target enrollmentJuly 2009

ConditionsHealthy Volunteers

InterventionsAZD2423 Placebo

DrugsAZD2423 Placebo

Overview

Phase: Phase 1
Intervention: AZD2423
Conditions: Healthy Volunteers
Sponsor: AstraZeneca
Enrollment: 80
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

November 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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

Arms & Interventions

A

AZD2423

Intervention: AZD2423

B

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

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