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
  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
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: 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 September 18, 2014