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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00690404

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Apr 1, 2008

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Drug: AZD2066

single oral dose

Outcome Measures

Primary Outcome Measures

AZ2066 pharmacokinetics [several samples within 72 hrs]

Secondary Outcome Measures

Effect of food on AZD2066 pharmacokinetics [several samples over 72 hrs]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

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.

Contacts and Locations

Locations

No locations specified.

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