AZD5069 Neutrophil Function Study

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Chemokine Receptor 2 (CXCR2) Antagonist

Treatments: Drug: 100 mg Placebo; Drug: 100 mg (50 mg x 2) AZD5069

Study type: Interventional

Funder types: Industry

Identifiers

NCT01480739

D3550C00017

Details and patient eligibility

About

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)

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

1

Experimental group

Description:

AZD5069 100 mg capsules (50 mg BD) for 7 days

Treatment:

Drug: 100 mg (50 mg x 2) AZD5069

2

Experimental group

Description:

Placebo twice daily for 7 days

Treatment:

Drug: 100 mg Placebo