Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers

This study is currently recruiting participants.

Verified by AstraZeneca, September 2009

First Received: March 12, 2009 Last Updated: September 9, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00861718

Purpose

Multiple Ascending Dose Study

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

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, 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 When Given in Multiple Ascending Oral Doses in Healthy Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the safety and tolerability of AZD7268 when given orally in multiple ascending doses 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. [ Time Frame: Serial blood samples for pharmacokinetic analysis will be collected on Days 1,2,3 and Days 9, 10, and 11 of the study. Additional pharmacokinetic samples will be collected on Days 6, 7, and 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2009
Estimated Study Completion Date:	October 2009

Arms	Assigned Interventions
AZD7268: Experimental	Drug: AZD7268 Capsule, Oral, QD Drug: AZD7268 Capsule, Oral, BID
Placebo: Placebo Comparator	Drug: Placebo Capsule, Oral BID

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
Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
History of seizure (including infancy febrile seizures) or family history of seizure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861718

Contacts

Contact: AstraZeneca Clinical Study Information

800-236-9933

Locations

United States, Pennsylvania
Research Site	Recruiting
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:	D1151C00003
Study First Received:	March 12, 2009
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00861718 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Phase 1
Healthy Volunteer

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 10, 2009