AZD5069 Neutrophil Function Study - Full Text View

Purpose

Study in healthy volunteer to see effect of AZD5069 and placebo on neutrophil number and function (phagocytosis and oxidative burst) in the circulation, following a burst of strenuous exercise and following subcutaneous injection of granulocyte-colony stimulating factor (G-CSF)

Condition	Intervention	Phase
Chemokine Receptor 2 (CXCR2) Antagonist	Drug: 100 mg (50 mg x 2) AZD5069 Drug: 100 mg Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Official Title:	A Randomised, Double-blind, Placebo-Controlled, Two-way Cross-over, Single Centre Study in Healthy Subjects to Assess the Effect of Oral Dosing of AZD5069 on Neutrophil Number and Function in Peripheral Blood and the Ability to Recruit Neutrophils Into the Circulation After Exercise and Subcutaneous

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in status of Neutrophil function (phagocytosis and oxidative burst) in subjects on AZD5069 and placebo [ Time Frame: Day -1, Day 1, Day 2, Day 3, Day 4 and 7 days after end of treatment. ] [ Designated as safety issue: No ]
Circulating neutrophils during exercise challenge measured by average neutrophil values over time [ Time Frame: Pre-dose, 10 min, 2h, 4 hours post exercise test ] [ Designated as safety issue: No ]
Circulating neutrophils following subcutaneous injection of granulocyte-colony stimulating factor (G-CSF) [ Time Frame: Pre-dose, 2h, 6h, 12h, 24h, 36 hours post subcutaneous G-CSF ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: Screening to Day 63 ] [ Designated as safety issue: Yes ]
Steady state 24 hour pharmacokinetic profile of the AZD5069 capsule following twice daily (bid) dosing [ Time Frame: Pre-dose on Days 1 - 4 On Day 3 with sampling pre-dose and at 1h, 2h, 3h, 5h, 8h, and 12 hours post dose ] [ Designated as safety issue: No ]
Steady state 24 hour profile of circulating neutrophils following twice daily dosing of AZD5069 and its relationship to plasma concentration [ Time Frame: Pre-dose and 1, 2, 3, 5, 8, 12 hours post each dose on Days 1 - 4, Day 6 and Day 7 ] [ Designated as safety issue: No ]
Changes in baseline of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs, and physical examination findings will be presented [ Time Frame: Screening to Day 63 ] [ Designated as safety issue: Yes ]

Enrollment:	30
Study Start Date:	December 2011
Study Completion Date:	July 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AZD5069 100 mg capsules (50 mg BD) for 7 days	Drug: 100 mg (50 mg x 2) AZD5069 Twice daily for 7 days
Experimental: 2 Placebo twice daily for 7 days	Drug: 100 mg Placebo Twice daily for 7 days

Detailed Description:

A Randomised, Double-blind, Placebo-Controlled, Two-way Cross-over, Single Centre Study in Healthy Subjects to Assess the Effect of Oral Dosing of AZD5069 on Neutrophil Number and Function in Peripheral Blood and the Ability to Recruit Neutrophils into the Circulation after Exercise and Subcutaneous

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Caucasian male or post-menopausal/surgical sterile females, aged 18 to 45 years inclusive at screening
Only women of non-childbearing potential are included in the study, ie, women who are permanently or surgically sterilised or post-menopausal
Non-smokers or ex-smokers with no smoking history the last 12 months prior to Visit 1 and a smoking history of less than 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for 1 year) at screening
Body mass index (BMI) >18 kg/m2 and ≤30 kg/m2 and a minimum weight of 50 kg

Exclusion Criteria:

Subjects with a history of or active or latent tuberculosis (TB), or close contact with anybody with active TB
Subjects with a history of malignancy or neoplastic disease (except successfully treated basal or squamous cell carcinoma of the skin)
Subjects who are pyrexial with a body temperature of greater than 37.7 C at Visit 2, or as judged by the Investigator
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) level ≥1.5 x upper limit of normal (ULN) at screening (Visit 2)
Peripheral blood neutrophils above or below the laboratory reference range at screening (Visit 2) hsCRP above the upper limit of the laboratory reference range at Visit 2

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480739

Locations

United Kingdom

London, UK, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Tim Mant, MD	Quintiles research Unit
Study Director:	Bengt Larsson, MD	AstraZeneca Medical Science Director

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01480739 History of Changes
Other Study ID Numbers:	D3550C00017
Study First Received:	November 24, 2011
Last Updated:	August 9, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Phase 1, AZD5069, safety and tolerability, healthy volunteer,

ClinicalTrials.gov processed this record on May 19, 2013