NCT00892944

Brief Summary

The purpose of this study is to determine if AZD2516 binds to mGluR5 receptors in the brain. This will then help to make accurate predictions of efficacy and dosing in the future development programme.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

October 28, 2009

Status Verified

October 1, 2009

First QC Date

April 28, 2009

Last Update Submit

October 27, 2009

Conditions

Healthy

Keywords

Positron Emission TomographyPhase 1Healthy volunteersAZD2516

Outcome Measures

Primary Outcomes (1)

  • Positron emission tomography to determine if AZD2516 can displace the radioligand [11C]AZ12713580 and describe relationship between AZD2516 exposure and mGluR5 receptor occupancy

    1 Month: Baseline and 3 PET examinations

Secondary Outcomes (2)

  • Safety and tolerability of AZD2516 by adverse events, vitals signs, ECG, body temperature and laboratory variables

    Assessed at each visit from baseline to follow-up visit

  • To investigate the Pharmacokinetics of AZD2516

    1 Month: 3 doses AZD2516 and 16 planned PK samples after each dose

Study Arms (1)

1

EXPERIMENTAL

AZD2516

Drug: AZD2516

Interventions

AZD2516DRUG

Fractionated single oral dose

1

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal MRI scan
  • Healthy male or non-fertile females
  • Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg

You may not qualify if:

  • History of disease or condition that may interfere with the objectives of the study
  • History of previous or ongoing psychiatric disease/condition
  • Concomitant medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Stockholm, Sweden

Location

Study Officials

  • Ingemar Bylesjo, MD, PhD

    AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

  • Michael O'Malley

    AstraZeneca R&D, Södertälje, Sweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 28, 2009

First Posted

May 5, 2009

Study Start

April 1, 2009

Study Completion

October 1, 2009

Last Updated

October 28, 2009

Record last verified: 2009-10

Locations

SE(1)