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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00861718
First received: March 12, 2009
Last updated: December 9, 2009
Last verified: December 2009

March 12, 2009
December 9, 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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00861718 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Healthy
  • Drug: AZD7268
    Capsule, Oral, QD
  • Drug: AZD7268
    Capsule, Oral, BID
  • Drug: Placebo
    Capsule, Oral BID
  • Experimental: AZD7268
    Interventions:
    • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00861718
D1151C00003
No
Mark A. Smith, M.D., AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Principal Investigator: Sylvan Hurewitz, M.D. AstraZeneca Clinical Pharmacology Unit, US
AstraZeneca
December 2009

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