Evaluation of Histamine H3 Receptor Radioligand [11C]AZ12807110 and Histamine H3 Receptor Occupancy of AZD5213 after Oral Administration

Study identifier:D3030C00003

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2009-010702-11

CTIS identifier:N/A

Study Complete

Official Title

An Open-label Positron Emission Tomography Study to Evaluate Use of Histamine H3 Receptor Radioligand [11C]AZ12807110 and to Determine Histamine H3 Receptor Occupancy of AZD5213 after Oral Administration to Healthy Volunteers

Medical condition

Brain distribution of [11C]AZ12807110 and AZD5213

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD5213

Sex

Female

Actual Enrollment

Study type

Interventional

Age

20 Years - 45 Years

Date

Study Start Date: 01 Nov 2010

Primary Completion Date: 01 Jun 2011

Study Completion Date: 01 Jun 2011

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/dynamics
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Uppsala, Sweden

Arms	Assigned Interventions
Experimental: Pilot panel [11C]AZ12807110 distribution and kinetics	Other: [11C]AZ12807110 Radioligand
Experimental: Main panel Histamine receptor occupancy reached by AZD5213	Other: [11C]AZ12807110 Radioligand

Documents available

D3030C00003 Clinical Study Report Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

Göran Göran Bertilsson

0733319129

goran.bertilsson@quintiles.com

Investigators

Principal Investigator

Björn Paulsson

AstraZeneca