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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD2066

• Registration Number: NCT00690404
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-04
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD2066	-

Primary Outcome Measures

Name	Time	Method
AZ2066 pharmacokinetics	several samples within 72 hrs

Secondary Outcome Measures

Name	Time	Method
Effect of food on AZD2066 pharmacokinetics	several samples over 72 hrs