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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00796965
First Posted: November 24, 2008
Last Update Posted: August 19, 2009
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.
Information provided by:
AstraZeneca
  Purpose
Single Ascending Dose Study

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, 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. ]

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. ]
  • 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. ]

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

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
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mark A. Smith, M.D, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00796965     History of Changes
Other Study ID Numbers: D1151C00001
First Submitted: November 20, 2008
First Posted: November 24, 2008
Last Update Posted: August 19, 2009
Last Verified: August 2009

Keywords provided by AstraZeneca:
Phase 1