Multiple Ascending Dose Study for AZD 7268 in Japanese Healthy Male Volunteers (JMAD)

December 14, 2010 updated by: AstraZeneca

A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 When Given in Multiple Ascending Oral Doses in Japanese Healthy Male Subjects

This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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
    • Sagamihara
      • Kanagawa, Sagamihara, 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:

  • Provision of Informed Consent
  • Healthy male subjects, with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

  • Inability to understand or cooperate with given information
  • Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, Hepatitis C and syphilis test
  • History of seizure (including infant febrile seizures) or family history of seizure

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

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Capsule, Oral, BID
Experimental: AZD7268
Drug: AZD7268
Capsule, Oral, BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigate the safety and tolerability of AZD7268 by Adverse Events.
Time Frame: From first dosing throughout the treatment period and including the follow-up period
From first dosing throughout the treatment period and including the follow-up period

Secondary Outcome Measures

Outcome Measure
Time Frame
Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma
Time Frame: Blood samples will be taken from pre-dose until 48 hours post last dose
Blood samples will be taken from pre-dose until 48 hours post last dose
Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine
Time Frame: Urine samples will be taken from post first dose until 48 hours post last dose.
Urine samples will be taken from post first dose until 48 hours post last dose.

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Tomoe Fujita, Kitasato University East Hospital, Kanagawa, 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

April 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

December 15, 2010

Last Update Submitted That Met QC Criteria

December 14, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D1151C00004

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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