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NCT00892944 Clinical Trial

An Open Label Positron Emission Tomography (PET) Study to Determine Central mGluR5 Receptor Occupancy of AZD2516

Healthy Clinical Trial

Official title:
An Open Label Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2516 After Oral Administration to Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00892944
Other study ID # D2080C00009
Secondary ID
Status Completed
Phase Phase 1
First received April 28, 2009
Last updated October 27, 2009
Start date April 2009
Est. completion date October 2009

Study information
Verified date October 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date October 2009
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 45 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- History of disease or condition that may interfere with the objectives of the study

- History of previous or ongoing psychiatric disease/condition

- Concomitant medication

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• AZD2516
Fractionated single oral dose

Locations
Country Name City State
Sweden Research Site Stockholm

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary To investigate the Pharmacokinetics of AZD2516 1 Month: 3 doses AZD2516 and 16 planned PK samples after each dose No
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