Evaluate Different Extended-release (ER) Tablets/Capsules of AZD1305 (2007-005765-38)

December 1, 2010 updated by: AstraZeneca

A Phase I, Two-part, Randomised, Open, Single-centre, Crossover Study to Evaluate Different Extended-release Formulations of AZD1305 When Given as Single Oral Doses to Healthy Male Volunteers

To study the properties of different tablets/capsules of AZD1305 in healthy male volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

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

16 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male between the age of 20 - 45
  • Non-smoking

Exclusion Criteria:

  • Potassium outside normal reference values
  • ECG findings outside normal range

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: 2x2 crossover
4 different AZD1305 ER formulations
Drug: AZD1305
Extended release capsules, oral single doses
Experimental: Part B: 3x3 crossover
2 different AZD1305 ER formulations and a reference formulation
Drug: AZD1305
Extended release capsules, oral single doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic variables
Time Frame: During all dosing visits
During all dosing visits

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events, ECG, safety laboratory, vital signs, physical examination
Time Frame: During the study
During the study

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Daniel Bradford, MD, MA, MBBS, DCPSA, PAREXEL Clinical Pharmacology Research UnitHarrow, United Kingdom

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

February 1, 2008

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

May 30, 2008

First Submitted That Met QC Criteria

June 2, 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 1, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D3190C00014

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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