A Phase I, Randomised, Double Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Oral Doses of AZD8566 in Healthy Volunteers

AstraZeneca1 site in 1 country108 target enrollmentAugust 2008

ConditionsHealthy Volunteer

InterventionsAZD8566 Placebo

DrugsAZD8566 Placebo

Overview

Phase: Phase 1
Intervention: AZD8566
Conditions: Healthy Volunteer
Sponsor: AstraZeneca
Enrollment: 108
Locations: 1
Primary Endpoint: Pharmacokinetic profile: concentration of AZD8566 in blood
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine how well tolerated and safe AZD8566 is at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

February 2009

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Provision of written informed consent.
•Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
•Females who are permanently or surgically sterile or postmenopausal.

Exclusion Criteria

•Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug
•History of any convulsions or seizures
•History of infection or at risk of infection due to recent surgery or trauma
•History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug

Arms & Interventions

1

Intervention: AZD8566

2

Intervention: Placebo

Outcomes

Primary Outcomes

Pharmacokinetic profile: concentration of AZD8566 in blood

Time Frame: Samples taken during Visit 2 (residential period) at up to 16 defined timepoints pre-dose and post- dose

Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events

Time Frame: Assessments taken at Visit 1 (enrolment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored throughout the study from Visit 1 to Visit 3 for adverse events.