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AZD8529 Single Ascending Dose Study (SAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00755378
First received: September 18, 2008
Last updated: March 25, 2009
Last verified: March 2009
History of Changes
  Purpose

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after single 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: Phase I, Single-Center, Randomized, Double-Blind, Placebo Controlled Single-Ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and PK of AZD8529 in Healthy Subjects Part B: A Randomized, Open Label Study to Assess the Effect of Food on AZD 8529

Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • To characterize the pharmacokinetics of AZD8529 in plasma and urine. [ Time Frame: Blood and urine samples will be taken during the study. ] [ Designated as safety issue: No ]
  • To asses the effect of food on the safety and pharmacokinetic profile of AZD8529. [ Time Frame: Safety assessments and blood and urine samples will be taken throughout the study. ] [ Designated as safety issue: No ]

Estimated Enrollment: 58
Study Start Date: September 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:

  • Healthy male or female subjects aged 18 to 45 years (inclusive) on Day 1. 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 3 months 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00755378

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, AStraZeneca
ClinicalTrials.gov Identifier: NCT00755378     History of Changes
Other Study ID Numbers: D1960C00001
Study First Received: September 18, 2008
Last Updated: March 25, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I

ClinicalTrials.gov processed this record on May 21, 2013