A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 After Single Ascending Doses in Healthy Male and/or Female Subjects

AstraZeneca1 site in 1 country203 target enrollmentJuly 2009

ConditionsHealthy

InterventionsAZD5069 Placebo

DrugsAZD5069 Placebo

Overview

Phase: Phase 1
Intervention: AZD5069
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 203
Locations: 1
Primary Endpoint: Safety and tolerability of AZD5069 assessing vitals signs (blood pressure, pulse rate,body temperature), ECG,laboratory variables (including high sensitivity C-reactive protein, circulating neutrophils), continuous cardiac monitoring using telemetry.
Status: Completed
Last Updated: 10 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 AZD5069 is at different dose levels in healthy male and/or females. The study will also investigate how quickly AZD5069 is absorbed into and cleared by the body.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

December 2009

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provision of signed and dated, written informed consent
•Healthy male or female (of non child bearing potential) caucasian subjects aged 18 to 65 years with suitable veins for cannulation or repeated venepuncture
•Body mass index of between 18 and 30 kg/m2 inclusive

Exclusion Criteria

•Subjects must not have 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 subjects ability to participate in the study
•Subjects must not have any history of gastrointestinal, liver or kidney disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body
•Subjects must not have had any significant illness or medical/surgical procedures or injuries with 4 weeks of administration of the investigational product

Arms & Interventions

Active

AZD5069 oral solution

Intervention: AZD5069

Placebo

Placebo oral solution

Intervention: Placebo

Outcomes

Primary Outcomes

Safety and tolerability of AZD5069 assessing vitals signs (blood pressure, pulse rate,body temperature), ECG,laboratory variables (including high sensitivity C-reactive protein, circulating neutrophils), continuous cardiac monitoring using telemetry.

Time Frame: Baselines assessments at Visit 1 (enrolment). Assessments pre-dose at Visit 2 and at protocol defined time-points post-dose. Follow up assessments at Visit 3.

Secondary Outcomes

Pharmacokinetic profile: concentration of AZD5069 in blood(Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.)
Pharmacodynamic profile: assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood(Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose.)
Measurement of the effect of AZD5069 on circulating neutrophils(Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.)