Japanese Single and Multiple Ascending Dose (JSMAD), Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of AZD5069 (JSMAD)

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 in Healthy Japanese Subjects After Single and Multiple Ascending Doses

This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple doses up to 11 days.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: AZD5069

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Croydon, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Japanese subjects with suitable veins for cannulation or repeated venepuncture.
• Have a body mass index (BMI) between 17 and 27 kg/m2 and a body weight between 45 and 80 kg
• Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

Exclusion Criteria:

• History of 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 subject's ability to participate in the study.
• History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
• Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product.
• Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD5069; Oral suspension
Placebo Comparator: 2	Drug: Placebo; Oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry	From screening period to follow-up visit 42 days (Maximum)

Secondary Outcome Measures

Outcome Measure	Time Frame
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 96 hours post-dose
Measurement of the effect of AZD5069 on blood cells	Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose
Pharmacokinetic profile: concentration of AZD5069 in blood	Baselines at Visit 1 or pre-dose Day 1, assessments Visit 2, post-dose until 96hr post final dose. Follow up assessments at Visit 3. Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Ulrike Lorch, Lorch, MD MFPM FRCA, Richmond Pharmacology Limited

Publications and helpful links

General Publications

• Cullberg M, Arfvidsson C, Larsson B, Malmgren A, Mitchell P, Wahlby Hamren U, Wray H. Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers. Drugs R D. 2018 Jun;18(2):149-159. doi: 10.1007/s40268-018-0236-x.

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: April 7, 2010
• First Posted (Estimate): April 8, 2010

Study Record Updates

• Last Update Posted (Estimate): June 25, 2015
• Last Update Submitted That Met QC Criteria: June 24, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Phase I; Japanese healthy volunteer; AZD5069
• Other Study ID Numbers: D3550C00005; 2009-018185-35 (EudraCT Number)