AZD0837 Extended Release (ER) Japan Study (ER J ph I)

July 10, 2009 updated by: AstraZeneca

A Single-blind, Randomised, Placebo-controlled, Parallel-group, Single Centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended-release Tablets AZD0837 After Single and Repeated Oral Administration to Young Healthy Male Japanese Subjects

This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

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

  • Japan
      • Kagoshima, Japan
        • 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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male Japanese subject aged between 20 to 45 years inclusive

Exclusion Criteria:

  • Acute illness (including ongoing or history of liver disease), trauma or surgical procedures within two weeks before Visit 1 or pre first dose in Visit 2
  • Intake of another investigational drug within 4 months before Visit 1 or pre first dose in Visit 2
  • Blood donation and/or sampling in excess of 200 mL of whole blood within the preceding 4 weeks, 400 mL of whole blood within the preceding 12 weeks and/or 1200 mL of whole blood within the preceding 12 months, before Visit 1 or pre first dose in Visit 2

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Low dose
Drug: AZD0837
tablet, oral, once daily, 1+5 days
Placebo Comparator: 4
placebo
Drug: Placebo
Placebo
Experimental: 2
Middle dose
Drug: AZD0837
tablet, oral, once daily, 1+5 days
Experimental: 3
High dose
Drug: AZD0837
tablet, oral, once daily, 1+5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects.
Time Frame: All assessments are made at each visit, at least daily, during the study.
All assessments are made at each visit, at least daily, during the study.

Secondary Outcome Measures

Outcome Measure
Time Frame
To investigate the pharmacokinetics (PK) of AZD0837, AR H069927XX and AR-H067637XX after single and repeated oral dosing of AZD0837 ER tablet, in Japanese healthy subjects.
Time Frame: Blood samples will be taken before and after study drug administration.
Blood samples will be taken before and after study drug administration.

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Hiroyuki Fukase, MD, PhD, CPC Clinic, Medipolis Medical Research Institute, Kagoshima, Japan

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

May 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Estimate)

July 13, 2009

Last Update Submitted That Met QC Criteria

July 10, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D1250C00055

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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