Study to Compare Different Formulations of AZD3355

December 2, 2010 updated by: AstraZeneca

A Double-blind, Randomized, Cross-over Design, Phase 1 Pharmacodynamic Study to Investigate the Effect of Different Formulations of AZD3355 for the Development of Paresthesiae After Dosing in Healthy Subjects

The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.

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

  • Sweden
    • Lulea
      • Varvsgatan, Lulea, Sweden
        • 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:

  • Provision of written informed consent
  • Female subjects with no childbearing potentials or using highly efficient contraceptive methods
  • Clinically normal physical findings

Exclusion Criteria:

  • Clinically significant illness within 2 weeks prior to the first dose of investigational product
  • History of clinically significant disease
  • Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
IR Formulation 65 mg
Drug: AZD3355
Single dose
Other Names:
  • Lesogaberan
Experimental: 2
IR Formulation 150 mg
Drug: AZD3355
Single dose
Other Names:
  • Lesogaberan
Experimental: 3
MR formulation, 1h 65 mg
Drug: AZD3355
Single dose
Other Names:
  • Lesogaberan
Experimental: 4
MR Formulation, 1h 150 mg
Drug: AZD3355
Single dose
Other Names:
  • Lesogaberan
Experimental: 5
MR Formulation, 2h 150 mg
Drug: AZD3355
Single dose
Other Names:
  • Lesogaberan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Specific AE questions
Time Frame: During 0-4 hours post dose
During 0-4 hours post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
PK variables
Time Frame: Frequent sampling up to 36 hours post dose
Frequent sampling up to 36 hours post dose
Safety variables (other adverse events, blood pressure, pulse, safety lab)
Time Frame: During the whole treatment period
During the whole treatment period

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Aslak Rautio, MD, Quintiles Hermelinen, Varvsgatan 53, SE-972 33 Luleå, Sweden

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, 2008

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 30, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Estimate)

December 3, 2010

Last Update Submitted That Met QC Criteria

December 2, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9120C00031
  • EudraCT nr 2007-007126-22

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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