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
  Purpose

Multiple Ascending Dose Study


Condition Intervention Phase
Healthy
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, Caregiver, 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 When Given in Multiple Ascending Oral Doses in Healthy Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: April 2009
Study Completion Date: October 2009
Arms Assigned Interventions
Experimental: AZD7268 Drug: AZD7268
Capsule, Oral, QD
Drug: AZD7268
Capsule, Oral, BID
Placebo Comparator: Placebo Drug: Placebo
Capsule, Oral BID

  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
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861718

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: NCT00861718     History of Changes
Other Study ID Numbers: D1151C00003
Study First Received: March 12, 2009
Last Updated: December 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase 1
Healthy Volunteer

ClinicalTrials.gov processed this record on July 31, 2014