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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00690404
First Posted: June 4, 2008
Last Update Posted: December 10, 2010
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.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Healthy Drug: AZD2066 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by AstraZeneca:

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

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

Enrollment: 20
Study Start Date: April 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD2066
single oral dose

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00690404


Sponsors and Collaborators
AstraZeneca
Investigators
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
  More Information

Responsible Party: Rolf Karlsten, M.D., Medical Science Director, Emerging Neuroscience, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00690404     History of Changes
Other Study ID Numbers: D0475C00005
First Submitted: June 2, 2008
First Posted: June 4, 2008
Last Update Posted: December 10, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
formulation
pharmacokinetic
crossover formulation
food effect
oral solution
healthy volunteers