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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00690404
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : December 10, 2010
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD2066 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Phase 1, Single-center, Randomized, Open-label, Two-way Crossover, Formulation and Food Effect Study in Healthy Volunteers, to Assess the Pharmacokinetics of AZD 2066 After Single Doses of a New Oral Solid Formulation and an Oral Solution
Study Start Date : April 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Experimental: 1 Drug: AZD2066
single oral dose

Primary Outcome Measures :
  1. AZ2066 pharmacokinetics [ Time Frame: several samples within 72 hrs ]

Secondary Outcome Measures :
  1. Effect of food on AZD2066 pharmacokinetics [ Time Frame: several samples over 72 hrs ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00690404

Sponsors and Collaborators
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Principal Investigator: Eleanor Lisbon, MD, MPH Quintiles, Inc. Overland Park, Kansas, USA
Study Chair: Heather Wray, MB, ChB, FFPM AstraZeneca Charnwood England
Study Chair: Ivan Eggens, MD AstraZeneca , Södertälje, Sweden
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Responsible Party: Rolf Karlsten, M.D., Medical Science Director, Emerging Neuroscience, AstraZeneca Pharmaceuticals Identifier: NCT00690404    
Other Study ID Numbers: D0475C00005
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 2010
Keywords provided by AstraZeneca:
crossover formulation
food effect
oral solution
healthy volunteers