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AZD6280 Multiple Ascending Dose Study (MAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681317
First received: May 19, 2008
Last updated: December 7, 2010
Last verified: December 2010
History of Changes
  Purpose

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD6280 after single and repeated ascending doses.


Condition Intervention Phase
Healthy Volunteer
 Drug: AZD6280
 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)
Official Title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6280 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: Assessments are made at each visit, at least daily, during the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation and characterization of the pharmacokinetics of AZD6280 [ Time Frame: Blood samples will be taken during the study. ] [ Designated as safety issue: No ]
  • Evaluation of the pharmacodynamic effects of AZD6280 [ 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 AZD6280. [ Time Frame: A single blood sample will be obtained. ] [ Designated as safety issue: No ]

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: AZD6280
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681317

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: NCT00681317     History of Changes
Other Study ID Numbers: D0850C00002
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 May 19, 2013