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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00953888

Collaborator

(none)

203

Enrollment

Location

Arms

Duration (Months)

40.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD5069 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

203 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active AZD5069 oral solution	Drug: AZD5069 Single dose of oral solution.
Placebo Comparator: Placebo Placebo oral solution	Drug: Placebo Single dose of oral solution.

Arm

Intervention/Treatment

Experimental: Active

AZD5069 oral solution

Drug: AZD5069

Single dose of oral solution.

Placebo Comparator: Placebo

Placebo oral solution

Drug: Placebo

Single dose of oral solution.

Outcome Measures

Primary Outcome Measures

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

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.]
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.]
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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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