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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
History of Changes

May 19, 2008
December 7, 2010
March 2008
July 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00681915 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
AZD7325 Multiple Ascending Dose Study
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

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD7325 after single and repeated ascending doses.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy Volunteer
Drug: AZD7325
Oral
Experimental: 1
Intervention: Drug: AZD7325
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00681915
D1140C00002
No
Mark A. Smith, MD, PhD Medical Science Sr. Director, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Principal Investigator: Sylvan J. Hurewitz, MD AstraZeneca Clinical Pharmacology Unit, US
AstraZeneca
December 2010

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