NCT00886067

Brief Summary

The primary purpose is to study the occupancy at the α4β2 neuronal nicotinic receptor's (NNRs) and to determine the relation between plasma concentration of AZD1446 and the occupancy at α4β2 NNRs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 10, 2009

Status Verified

September 1, 2009

Enrollment Period

4 months

First QC Date

April 21, 2009

Last Update Submit

September 9, 2009

Conditions

Healthy

Keywords

AZD1446PET examination

Outcome Measures

Primary Outcomes (2)

  • Determine whether and to what extent AZD1446 can displace radioligand 2-[18F]-F-A85380 from binding to α4β2 neuronal nicotinic receptors (NNRs) and to describe the relationship between plasma concentrations of AZD1446 and its occupancy at α4β2 NNRs.

    One PET assessment on baseline day and one PET assessment at the drug treatment day

  • Plasma concentration (Cmax, tmax, AUC)

    During time period of the PET assessment

Secondary Outcomes (1)

  • Safety and tolerability (AEs, vital signs, lab)

    During the whole study

Study Arms (2)

2-[18F]-F-A85380

EXPERIMENTAL

Single microdose

Radiation: 2-[18F]-F-A85380

AZD1446

EXPERIMENTAL

Single oral administration

Drug: AZD1446

Interventions

AZD1446DRUG

Solution, oral, single dose

AZD1446
2-[18F]-F-A85380RADIATION

iv, single dose

2-[18F]-F-A85380

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physically healthy volunteers
  • Body weight between 50 to 100 kg and body mass index (BMI) between 19 and 30 kg/m2

You may not qualify if:

  • History of any clinically significant disease or disorder
  • History of severe allergy/hypersensitivity reactions
  • Participation in a PET examination as part of a scientific study during the past twelve months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Stockholm, Sweden

Location

MeSH Terms

Interventions

3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane2-fluoro-3-(2-azetidinylmethoxy)pyridine

Study Officials

  • Björn Paulsson, MD, PhD

    AstraZeneca Södertälje

    STUDY DIRECTOR

  • Ingemar, Bylesjö, MD, PhD

    AstraZeneca CPU Huddinge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 22, 2009

Study Start

April 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 10, 2009

Record last verified: 2009-09

Locations

SE(1)