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AZD8529 Multiple Ascending Dose Study in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00765492
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : June 26, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: AZD8529 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
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
Study Start Date : October 2008
Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: 1 Drug: AZD8529
Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  1. 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 :
  1. To characterize the pharmacokinetics of AZD8529 in plasma [ Time Frame: Blood samples will be taken during the study. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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
Study Director: Mark Smith, MD, PhD AstraZeneca

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

Keywords provided by AstraZeneca:
Phase I