Phase I 2-Way Crossover Study to Assess Relative BA of Tablet Versus Liquid Suspension and Food Effect on Tablet Formulation - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00867685

Purpose

The purpose of this study is to compare the liquid suspension form of AZD 2624 to a tablet form of the same drug. This study will also study the effect of food on the tablet form of the drug.

Condition	Intervention	Phase
Healthy	Drug: AZD2624	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Crossover Assignment, Bio-availability Study
Official Title:	A Phase I, Randomized, Open Label, 2-Way Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of AZD2624 (Tablet Versus Liquid Suspension) Followed by an Additional Period to Assess the Food Effect on the Tablet

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Serial blood draws will be used to measure the plasma levels of AZD2624 for the liquid suspension and the tablet formulation in a fed and fasted state. [ Time Frame: Seventeen blood draws will be collected during each treatment period for a total of 51 samples for the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety will be measured by the collection of AEs, ECGs, physical exams, and vital signs. [ Time Frame: Subjects inquiry on AE daily, ECGs collected at 2 timepoints each period, clinical labs collected at 3 timepoints each period, physical exams completed 3 timepoints each period, and vital signs collected each day of each period ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	March 2009
Study Completion Date:	April 2009

Arms	Assigned Interventions
Treatment A: Experimental Single oral dose of 40 mg AZD2624 liquid suspension in a fasted state.	Drug: AZD2624 Single dose of 40 mg AZD2624 liquid suspension, PO
Treatment B: Experimental Single oral dose of 40 mg (2x20mg tablets)AZD2624 in a fasted state.	Drug: AZD2624 Single dose of 40 mg AZD 2624 (2x20mg tablets), PO
Treatment C: Experimental Single oral dose of 40 mg (2x20mg tablets) in a fed state.	Drug: AZD2624 Single dose of 40 mg AZD 2624 (2x20mg tablets), PO

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male and female volunteers

Exclusion Criteria:

Donation of plasma or blood products within one month of of screening
Clinically relevant abnormalities in physical examination, vital signs,ECG, clinical chemistry, hematology, or urinalysis.
Previous participation in an AD2624 study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867685

Locations

United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Sylvan Hurewitz, MD

AstraZeneca Clinical Pharmacology Unit, US

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Mark Smith, MD, PhD, Senior Medical ScienceDirector Emerging Neuroscience )
Study ID Numbers:	D0970C00008
Study First Received:	March 18, 2009
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00867685 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by AstraZeneca:

Healthy Volunteers

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009