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
  Purpose

Single Ascending Dose Study


Condition Intervention Phase
Healthy Volunteer
Drug: AZD7268
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 After Single Ascending Oral Doses in Healthy Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: December 2008
Study Completion Date: March 2009
Arms Assigned Interventions
Experimental: 1 Drug: AZD7268
Solution/Capsule, Oral, once daily
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796965

Locations
United States, Pennsylvania
Research Site
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: Mark A. Smith, M.D, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00796965     History of Changes
Other Study ID Numbers: D1151C00001
Study First Received: November 20, 2008
Last Updated: August 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase 1

ClinicalTrials.gov processed this record on April 17, 2014