Study to Investigate the Safety, Tolerability and Activity of AZD5069 When Given as a Single Dose to Healthy Male and/or Female Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD5069; Drug: Placebo

• Registration Number: NCT00953888
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	AZD5069	AZD5069 oral solution
Placebo	Placebo	Placebo oral solution

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Nottingham, United Kingdom