AZD8529 Single Ascending Dose Study in Healthy Japanese Subjects (JSAD)

August 18, 2009 updated by: AstraZeneca

A Phase I, Single-Centre, Randomised, Double-Blind, Placebo Controlled Single-Ascending Dose, Study to Assess the Safety, Tolerability, Pharmacokinetics of AZD8529 in Healthy Male Japanese Subjects

This is a Phase I, double-blind, placebo-controlled, randomised within each dose group, single ascending dose study, with the objective to assess the safety, tolerability and pharmacokinetic profile of AZD8529 in healthy Japanese subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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

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 subjects aged 20 to 45 years (inclusive)
  • Have a body mass index (BMI) between 18 and 27 kg/m 2 (inclusive) and weigh at least 50 kg.least 50 kg.

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.
  • Any clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, haematology or urinalysis as judged by the Investigator and/or Sponsor.
  • Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
Oral
EXPERIMENTAL: 1
Drug: AZD8529
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To asses the safety:Adverse events, vital signs, physical examinations, telemetry, dECGs, clinical chemistry and haematology labs including testosterone, prolactin, LH, FSH and TSH, and urinalysis.
Time Frame: From screening period to follow-up, 42 days (maiximum).
From screening period to follow-up, 42 days (maiximum).

Secondary Outcome Measures

Outcome Measure
Time Frame
To characterize the pharmacokinetics of AZD8529 in plasma and urine.
Time Frame: Blood and urine sampling from pre-dose until 12 days post dose.
Blood and urine sampling from pre-dose until 12 days post dose.
To collect and store DNA for future exploratory research
Time Frame: One blood sampling after randomisation.
One blood sampling after randomisation.

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

April 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

April 21, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (ESTIMATE)

April 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2009

Last Update Submitted That Met QC Criteria

August 18, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D1960C00003
  • 2009-009940-22

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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