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:

March 12, 2009
March 13, 2009
December 10, 2009
April 2009
Not Provided
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. ]
Same as current
Complete list of historical versions of study NCT00861718 on Archive Site
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 ]
Same as current
Not Provided
Not Provided
Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers
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
Multiple Ascending Dose Study
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Drug: AZD7268
    Capsule, Oral, QD
  • Drug: AZD7268
    Capsule, Oral, BID
  • Drug: Placebo
    Capsule, Oral BID
  • Experimental: AZD7268
    • Drug: AZD7268
    • Drug: AZD7268
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2009
Not Provided

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Mark A. Smith, M.D., AstraZeneca Pharmaceuticals
Not Provided
Principal Investigator: Sylvan Hurewitz, M.D. AstraZeneca Clinical Pharmacology Unit, US
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP