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

Purpose

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	Intervention	Phase
Healthy	Drug: AZD5069 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Further study details as provided by AstraZeneca:

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. [ 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic profile: concentration of AZD5069 in blood [ Time Frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose. ] [ Designated as safety issue: No ]
Measurement of the effect of AZD5069 on circulating neutrophils [ Time Frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose. ] [ Designated as safety issue: No ]
Pharmacodynamic profile: assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood [ Time Frame: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose. ] [ Designated as safety issue: No ]

Enrollment:	203
Study Start Date:	July 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953888

Locations

United Kingdom
Research Site
Nottingham, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Andrew Sparrow, BSc, BMedSci, BM,BS

AstraZeneca Clinical Pharmacology Unit, Queens Medical Centre, Nottingham NG7 2UH

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00953888 History of Changes
Other Study ID Numbers:	D3550C00001
Study First Received:	August 5, 2009
Last Updated:	January 20, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Healthy volunteer
Single ascending dose
Safety
Tolerability
Healthy volunteer study

ClinicalTrials.gov processed this record on June 17, 2013