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CompletedNCT00690404Updated Dec 10, 2010

AZD 2066 Single Dose Formulation and Food Effect Study in Healthy Volunteers

A Phase 1 interventional study of AZD2066 in Healthy, sponsored by AstraZeneca. Completed. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-10.

Sponsored by AstraZeneca · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy

Keywords

  • formulation
  • pharmacokinetic
  • crossover formulation
  • food effect
  • oral solution
  • healthy volunteers
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    1

    Drug: AZD2066

Interventions

  • DrugAZD2066

    single oral dose

06

What researchers measure

Primary outcomes

  1. AZ2066 pharmacokinetics

    Time frame: several samples within 72 hrs

Secondary outcomes

  1. Effect of food on AZD2066 pharmacokinetics

    Time frame: several samples over 72 hrs

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00690404
Lead sponsor
AstraZeneca
First posted
Jun 4, 2008
Start date
Apr 2008
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Dec 10, 2010

Study contacts

Eleanor Lisbon, MD, MPH
principal investigator · Quintiles, Inc. Overland Park, Kansas, USA
Heather Wray, MB, ChB, FFPM
study chair · AstraZeneca Charnwood England
Ivan Eggens, MD
study chair · AstraZeneca , Södertälje, Sweden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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