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

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AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Brain Distribution of [11C]AZ12807110 and AZD5213

Treatments

Drug: AZD5213
Other: [11C]AZ12807110

Study type

Interventional

Funder types

Industry

Identifiers

NCT01194986
D3030C00003
2009-010702-11 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to investigate features of radioligand [11C]AZ12807110 and how much AZD5213 displaces radioligand from histamine receptors when given together.

Enrollment

13 patients

Sex

Female

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male and/or female volunteers between 20 to 45 years with suitable veins for cannulation or repeated venipuncture (pilot panel)
  • Female must be of non-child bearing potential (pilot panel)
  • BMI between 18 to 30 30 kg/m2
  • Normal MRI scan
  • Provision of signed, written and dated informed consent

Exclusion criteria

  • History of any clinically significant disease or disorder
  • History or presence of gastrointestinal, hepatic or renal disease
  • Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome
  • History of severe allergy or hypersensitivity or ongoing allergy or hypersensitivity
  • Healthy volunteer suffers from claustrophobia

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

13 participants in 2 patient groups

Pilot panel
Experimental group
Description:
[11C]AZ12807110 distribution and kinetics
Treatment:
Other: [11C]AZ12807110
Main panel
Experimental group
Description:
Histamine receptor occupancy reached by AZD5213
Treatment:
Drug: AZD5213
Other: [11C]AZ12807110

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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