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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD5069; Drug: Placebo

• Registration Number: NCT01100047
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-24
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-08
• Study Start: 2010-05
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD5069	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Croydon, United Kingdom