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AZD8529 Multiple Ascending Dose Study in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00765492
First Posted: October 3, 2008
Last Update Posted: June 26, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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. ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetics of AZD8529 in plasma [ Time Frame: Blood samples will be taken during the study. ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765492


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

Responsible Party: Mark A. Smith, MD; Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00765492     History of Changes
Other Study ID Numbers: D1960C00002
First Submitted: October 2, 2008
First Posted: October 3, 2008
Last Update Posted: June 26, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
Phase I