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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD2516

• Registration Number: NCT00892944
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-05-04
• Study First Posted: 2009-05-05
• Status Verified: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2009-10-27
• Last Update Posted: 2009-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD2516	AZD2516

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden