AZD7325 Multiple Ascending Dose Study (MAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681915
First received: May 19, 2008
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD7325 after single and repeated ascending doses.


Condition Intervention Phase
Healthy Volunteer
Drug: AZD7325
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of Non-child Bearing Potential

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs [ Time Frame: Alssessments are made at each visit, at least daily, during the study. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation and characterization of the pharmacokinetics of AZD7325 when given orally in multiple ascending doses [ Time Frame: Blood samples will be taken during the study. ] [ Designated as safety issue: No ]
  • Evaluation of the pharmacodynamic effects of AZD7325 [ Time Frame: Test batteries will be performed at specified times both before and following study drug administration. ] [ Designated as safety issue: No ]
  • Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD7325. [ Time Frame: A single blood sample will be obtained. ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: March 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD7325
Oral

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female subjects must be of non-child bearing potential.

Exclusion Criteria:

  • Clinically significant illness within 2 weeks before the study start.
  • Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
  • Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
  • Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
  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: NCT00681915

Locations
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Sylvan J. Hurewitz, MD AstraZeneca Clinical Pharmacology Unit, US
  More Information

No publications provided

Responsible Party: Mark A. Smith, MD, PhD Medical Science Sr. Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00681915     History of Changes
Other Study ID Numbers: D1140C00002
Study First Received: May 19, 2008
Last Updated: December 7, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by AstraZeneca:
Phase I
Pharmacokinetics

ClinicalTrials.gov processed this record on July 20, 2014