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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00796965
First received: November 20, 2008
Last updated: August 18, 2009
Last verified: August 2009

November 20, 2008
August 18, 2009
December 2008
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00796965 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects
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

Single Ascending Dose Study

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Healthy Volunteer
  • Drug: AZD7268
    Solution/Capsule, Oral, once daily
  • Drug: Placebo
  • Experimental: 1
    Intervention: Drug: AZD7268
  • Placebo Comparator: 2
    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
48
March 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
  • 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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00796965
D1151C00001
No
Mark A. Smith, M.D, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Principal Investigator: Sylvan Hurewitz, M.D. AstraZeneca Clinical Pharmacology Unit, US
AstraZeneca
August 2009

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