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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00861718
Recruitment Status : Completed
First Posted : March 13, 2009
Last Update Posted : December 10, 2009
Information provided by:

Brief Summary:
Multiple Ascending Dose Study

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD7268 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date : April 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: AZD7268 Drug: AZD7268
Capsule, Oral, QD
Drug: AZD7268
Capsule, Oral, BID
Placebo Comparator: Placebo Drug: Placebo
Capsule, Oral BID

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00861718

United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Principal Investigator: Sylvan Hurewitz, M.D. AstraZeneca Clinical Pharmacology Unit, US

Responsible Party: Mark A. Smith, M.D., AstraZeneca Pharmaceuticals Identifier: NCT00861718     History of Changes
Other Study ID Numbers: D1151C00003
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: December 10, 2009
Last Verified: December 2009

Keywords provided by AstraZeneca:
Phase 1
Healthy Volunteer