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
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, see Learn About Clinical Studies.

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 October 23, 2014