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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01100047

Collaborator

(none)

Enrollment

Location

Arms

9.1

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD5069 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Drug: AZD5069

Oral suspension

Placebo Comparator: 2

Drug: Placebo

Oral suspension

Outcome Measures

Primary Outcome Measures

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

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Croydon		United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Ulrike Lorch, Lorch, MD MFPM FRCA, Richmond Pharmacology Limited

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

CSR Synopsis

Publications

None provided.

Responsible Party:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01100047

Other Study ID Numbers:

D3550C00005
2009-018185-35

First Posted:

Apr 8, 2010

Last Update Posted:

Jun 25, 2015

Last Verified:

Jun 1, 2015

Keywords provided by AstraZeneca

Phase I

Japanese healthy volunteer

AZD5069

Study Results

No Results Posted as of Jun 25, 2015