Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects

This study has been completed.

First Received: November 20, 2008 Last Updated: May 7, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00796965

Purpose

Single Ascending Dose Study

Condition	Intervention	Phase
Healthy Volunteer	Drug: AZD7268 Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Single Group Assignment, Safety Study
Official Title:	A Phase I, Single-Center, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the safety and tolerability of single ascending dose administration of AZD7268 when given orally to healthy male subjects and female subjects of non-childbearing potential. [ Time Frame: Safety assessments are made at each visit, at least daily, during the study. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To characterize the pharmacokinetics of AZD7268 in plasma and urine. [ Time Frame: Blood and urine samples will be taken during the study. ] [ Designated as safety issue: No ]
To assess the effect of food on the safety and pharmacokinetic profile of AZD7268. [ Time Frame: Safety assessments and blood and urine samples will be taken throughout the study. ] [ Designated as safety issue: No ]

Arms	Assigned Interventions
1: Experimental	Drug: AZD7268 Solution/Capsule, Oral, once daily
2: Placebo Comparator	Drug: Placebo

Eligibility

Criteria

Inclusion Criteria:

Provision of Informed Consent
Healthy male subjects and female subjects (of non-child bearing potential) with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

Inability to understand or cooperate with given information
Positive human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology, and urinanalysis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796965

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Sylvan Hurewitz, M.D.

AstraZeneca Clinical Pharmacology Unit, US

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Mark A. Smith, M.D )
Study ID Numbers:	D1151C00001
Study First Received:	November 20, 2008
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00796965 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Phase 1

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009