A Study to Evaluate Safety and Tolerability After Oral Dosing of AZD1656 in Healthy Volunteers

December 2, 2010 updated by: AstraZeneca

A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD1656 in Healthy Male Subjects

The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in healthy male subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

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

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Provision of informed consent
  • Clinically normal physical findings and laboratory values as judged by the investigator including negative test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to hepatitis C virus.

Exclusion Criteria:

  • Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the Investigational Product
  • History of psychiatric or somatic disease/condition that may interfere with the objectives of the study, as judged by the investigator

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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
8 increasing oral single doses given to 8 groups (3 on active and 1 on placebo in each group)
Drug: AZD1656
Dose escalation to achieve maximum tolerated dose
Drug: AZD1656
Oral single dose
Experimental: 2
2 oral doses of AZD1656 given to 2 groups together with food
Drug: AZD1656
Dose escalation to achieve maximum tolerated dose
Drug: AZD1656
Oral single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety variables (AE's, BP, pulse, lab variables, and ECG)
Time Frame: Safety variables taken repeatedly during 24 hours on study day sessions
Safety variables taken repeatedly during 24 hours on study day sessions

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic variables
Time Frame: Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions
Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions
Pharmacodynamic variables
Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions
Blood samples taken repeatedly during 24 hours on study day sessions

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Klas Malmberg, MD, PhD, AstraZeneca R&D Mölndal
  • Principal Investigator: Sylvan Hurewitz, MD, AstraZeneca CPU, Philadelphia, PA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 29, 2008

First Submitted That Met QC Criteria

July 31, 2008

First Posted (Estimate)

August 1, 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

Other Study ID Numbers

  • D1020C00001

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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