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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00690404
First received: June 2, 2008
Last updated: December 8, 2010
Last verified: December 2010
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of food on AZD2066 pharmacokinetics [ Time Frame: several samples over 72 hrs ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 2, 2008
Last Updated: December 8, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014