AZD8529 Multiple Ascending Dose Study in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00765492
First received: October 2, 2008
Last updated: June 25, 2009
Last verified: June 2009
  Purpose

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after multiple ascending doses


Condition Intervention Phase
Healthy Volunteer
Drug: AZD8529
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, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8529 When Given as Single and Multiple Ascending Oral Doses in Healthy Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the safety and tolerability of multiple dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential. [ Time Frame: each visit, at least daily, during the study. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetics of AZD8529 in plasma [ Time Frame: Blood samples will be taken during the study. ] [ Designated as safety issue: No ]

Estimated Enrollment: 47
Study Start Date: October 2008
Study Completion Date: March 2009
Arms Assigned Interventions
Experimental: 1 Drug: AZD8529
oral
Placebo Comparator: 2 Drug: Placebo
oral

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30months of the first administration of investigational prod
  • Plasma donation within one month of screening or any blood donation/blood loss > 500mL during the 3 months prior to screening
  • 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: NCT00765492

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Smith, MD, PhD AstraZeneca
  More Information

No publications provided

Responsible Party: Mark A. Smith, MD; Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00765492     History of Changes
Other Study ID Numbers: D1960C00002
Study First Received: October 2, 2008
Last Updated: June 25, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I

ClinicalTrials.gov processed this record on October 23, 2014