AZD8529 Single Ascending Dose Study (SAD)

March 25, 2009 updated by: AstraZeneca

Phase I, Single-Center, Randomized, Double-Blind, Placebo Controlled Single-Ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and PK of AZD8529 in Healthy Subjects Part B: A Randomized, Open Label Study to Assess the Effect of Food on AZD 8529

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after single ascending doses

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

58

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, 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

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or female subjects aged 18 to 45 years (inclusive) on Day 1. Female subjects must be of non-child bearing potential.

Exclusion Criteria:

  • Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of investigational prod
  • Plasma donation within one month of screening or any blood donation/blood loss > 500mL during the 3 months prior to screening
  • Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

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
  • 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 assess the safety and tolerability of single dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.
Time Frame: at each visit, at least daily, during the study.
at each visit, at least daily, during the study.

Secondary Outcome Measures

Outcome Measure
Time Frame
To characterize the pharmacokinetics of AZD8529 in plasma and urine.
Time Frame: Blood and urine samples will be taken during the study.
Blood and urine samples will be taken during the study.
To asses the effect of food on the safety and pharmacokinetic profile of AZD8529.
Time Frame: Safety assessments and blood and urine samples will be taken throughout the study.
Safety assessments and blood and urine samples will be taken throughout the study.

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Sylvan J Hurewitz, MD, AstraZeneca Clinical Pharmacology Unit, US

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

September 1, 2008

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (ESTIMATE)

September 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 26, 2009

Last Update Submitted That Met QC Criteria

March 25, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D1960C00001

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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