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

NCT00690404 — Phase 1, Completed, 20 participants, AstraZeneca

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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

Registry	NCT00690404
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none
Enrollment	20 (Actual)
Sponsor	AstraZeneca (Industry)
Conditions	Healthy
Interventions	AZD2066 (Drug)
Dates	start 2008-04-01, primary completion 2008-06-01, completion 2008-06-01, first posted 2008-06-04, last updated 2010-12-10

-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

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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: AZD2066

AZD2066 (Drug): single oral dose

+Outcome measures

Primary outcomes

AZ2066 pharmacokinetics [several samples within 72 hrs]

Secondary outcomes

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

+Eligibility

Sex: All, ages: 20 Years to 45 Years, accepts healthy volunteers

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.

+Investigators

Eleanor Lisbon, MD, MPH, Principal investigator, Quintiles, Inc. Overland Park, Kansas, USA
Heather Wray, MB, ChB, FFPM, Study chair, AstraZeneca Charnwood England
Ivan Eggens, MD, Study chair, AstraZeneca , Södertälje, Sweden