Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Occupancy of SEROQUEL

AstraZeneca10 enrolled

Overview

The aim of this study is to relate pharmacokinetics of two different formulations of quetiapine to PET measured receptor occupancy in the brains of healthy subjects.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Depression

Interventions

SEROQUEL XR (quetiapine)DRUG

repeated dose of oral tablets, 8 times per subject

SEROQUEL IR (quetiapine)DRUG

repeated dose of oral tablets, 4 times per subject

radioligand [11C]racloprideDRUG

single dose of iv admin, 5 times per subject

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Normal MRI scan * Body mass index 19-30 kg/m2 and weight of 50-100 kg * Clinically normal physical findings, medical history and laboratory values Exclusion Criteria: * Trauma or sickness last 2 weeks before the first PET examination. * A history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease or other condition as judged by the Investigator * Any previous participation in a PET study * Subjects suffer from claustrophobia

Locations (1)

Research Site

Stockholm, Sweden

Outcomes

Primary Outcomes

Positron emission tomography using the radioligand [11C]raclopride

Time frame: 5 visits

Secondary Outcomes

Adverse Events (AEs), vital signs and changes in laboratory parameters, physical examinations, Alertness Visual Analogue Scale.

Time frame: 5 visits. Some tests will be done several times per visit. All tests will not be performed at every visit.

Pharmacokinetics of quetiapine and its main active metabolite

Time frame: 22 samples

Data from ClinicalTrials.gov

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