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

AstraZeneca6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AZD2516DRUG

Fractionated single oral dose

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Stockholm, Sweden

Outcomes

Primary Outcomes

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

Time frame: 1 Month: Baseline and 3 PET examinations

Secondary Outcomes

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

Time frame: Assessed at each visit from baseline to follow-up visit

To investigate the Pharmacokinetics of AZD2516

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

Data from ClinicalTrials.gov

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