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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00892944

Enrollment

Registered

2009-05-05

Start date

2009-04-30

Completion date

2009-10-31

Last updated

2009-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Positron Emission Tomography, Phase 1, Healthy volunteers, AZD2516

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.

Interventions

DRUGAZD2516

Fractionated single oral dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026