NCT00690404

Brief Summary

A open label two way crossover formulation and food effect study in healthy volunteers to assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an oral solution

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_1 healthy

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, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

June 2, 2008

Last Update Submit

December 8, 2010

Conditions

Healthy

Keywords

formulationpharmacokineticcrossover formulationfood effectoral solutionhealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • AZ2066 pharmacokinetics

    several samples within 72 hrs

Secondary Outcomes (1)

  • Effect of food on AZD2066 pharmacokinetics

    several samples over 72 hrs

Study Arms (1)

1

EXPERIMENTAL
Drug: AZD2066

Interventions

AZD2066DRUG

single oral dose

1

Eligibility Criteria

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

You may qualify if:

  • Clinical normal physical findings, including BP, pulse rate \>45 bpm, ECG and laboratory assessments
  • Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg

You may not qualify if:

  • History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
  • History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AZD2066

Study Officials

  • Eleanor Lisbon, MD, MPH

    Quintiles, Inc. Overland Park, Kansas, USA

    PRINCIPAL INVESTIGATOR

  • Heather Wray, MB, ChB, FFPM

    AstraZeneca Charnwood England

    STUDY CHAIR

  • Ivan Eggens, MD

    AstraZeneca , Södertälje, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 2, 2008

First Posted

June 4, 2008

Study Start

April 1, 2008

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

December 10, 2010

Record last verified: 2010-12