AZD7325 Single Ascending Dose Study in Healthy Male Japanese Subjects (JSAD)

March 17, 2009 updated by: AstraZeneca

A Phase I,Single-Center,Randomised,Double-Blind,Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7325 in Healthy Male Japanese Subjects

This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose administration to healthy male Japanese volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Body mass index (BMI) : 18 to 27 kg/m 2

Exclusion Criteria:

  • Clinically relevant disease and/or abnormalities (past or present)
  • Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
  • Use of any medication or herbal preparation within 14 days of Study day 1 through the Follow-up Visit other than paracetamol (up to 3 g/day)
  • Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the first study day or inability to refrain from smoking during the study confinement period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: AZD7325
Capsule for oral, single dose
Placebo Comparator: 2
Drug: Placebo
Placebo capsule for oral, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerabilityThe nature and incidence of adverse events (AEs), vital signs,physical examinations,electrocardiograms (ECGs)and laboratory assessments.
Time Frame: During the study
During the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters for AZD7325
Time Frame: During residential period
During residential period
Genetic analysis of the genes involved in the pharmacokinetics and safety and tolerability to AZD7325 treatment may be performed. Participation in the exploratory genetic study is optional for the subjects.
Time Frame: During the study
During the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 8, 2008

First Submitted That Met QC Criteria

October 8, 2008

First Posted (Estimate)

October 9, 2008

Study Record Updates

Last Update Posted (Estimate)

March 18, 2009

Last Update Submitted That Met QC Criteria

March 17, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D1140C00010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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