NCT00803855

Brief Summary

The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2008

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

December 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 15, 2009

Status Verified

May 1, 2009

Enrollment Period

4 months

First QC Date

December 5, 2008

Last Update Submit

May 14, 2009

Conditions

Healthy

Keywords

single dosepharmacokineticssafetyhealthy volunteersfood interactionAZD1446

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables

    From first to last visit

Secondary Outcomes (2)

  • Determine the single ascending dose pharmacokinetics of AZD1446

    PK sampling taken at defined timepoints during residential period

  • Determine the single dose of AZD1446 on food interaction

    From first to last visit

Study Arms (2)

AZD1446 Oral or placebo

EXPERIMENTAL

Single oral administration of AZD1446 or placebo

Drug: AZD1446

AZD1446 Oral, with or without food

EXPERIMENTAL

Single oral administration of AZD1446 with or without food

Drug: AZD1446

Interventions

AZD1446DRUG

oral, single dose

AZD1446 Oral or placeboAZD1446 Oral, with or without food

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • physical healthy volunteers
  • weight between 50 to 100 kg and a 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research site

Huddinge, Sweden

Location

MeSH Terms

Interventions

3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane

Study Officials

  • Didier Meulien, MD, PhD, MSD

    AstraZeneca Södertälje

    STUDY DIRECTOR

  • Ingemar Bylesjö, MD, PhD

    AstraZeneca CPU Huddinge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 8, 2008

Study Start

December 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

May 15, 2009

Record last verified: 2009-05

Locations

SE(1)