Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD2516 to Healthy Volunteers

December 12, 2008 updated by: AstraZeneca

A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-Controlled Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 in Young and Elderly Healthy Volunteers After Oral Single Ascending Doses

The primary purpose of this study is to assess the safety and tolerability of AZD2516 following administration of a single dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

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
      • Stockholm, 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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy white males or non-fertile females between 20 to 45 years and 65 to 80 years old.
  • Weight between 50 to 100 kg and a body mass index (BMI) between 19 to 28 kg/m2

Exclusion Criteria:

  • History of previous or ongoing psychiatric disease.
  • Abnormalities in ECG that may interfere with interpretation of data.

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Solution administered only once
Experimental: AZD2516
Drug: AZD2516
Solution administered once orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of AZD2516 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
Time Frame: From first to last visit
From first to last visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of AZD2516 by assessment of non-serious adverse events
Time Frame: Collected from start of residential period until last visit.
Collected from start of residential period until last visit.
Determine the single ascending dose pharmacokinetics of AZD2516
Time Frame: PK sampling taken at defined timepoints during residential period
PK sampling taken at defined timepoints during residential period

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Bo Fransson, MD, AstraZeneca
  • Study Chair: Lars Ståhle, MD, PhD, 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

September 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 16, 2008

First Submitted That Met QC Criteria

September 17, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Estimate)

December 15, 2008

Last Update Submitted That Met QC Criteria

December 12, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D2080C00001
  • EudractCT: 2008-003598-42

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.

Subscribe