AZD7325 Multiple Ascending Dose Study (MAD)

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of Non-child Bearing Potential

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD7325 after single and repeated ascending doses.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: AZD7325

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Clinically significant illness within 2 weeks before the study start.
• Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
• Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
• Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD7325; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs	Alssessments are made at each visit, at least daily, during the study.

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the pharmacodynamic effects of AZD7325	Test batteries will be performed at specified times both before and following study drug administration.
Evaluation and characterization of the pharmacokinetics of AZD7325 when given orally in multiple ascending doses	Blood samples will be taken during the study.
Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD7325.	A single blood sample will be obtained.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Sylvan J. Hurewitz, MD, AstraZeneca Clinical Pharmacology Unit, US

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: May 19, 2008
• First Submitted That Met QC Criteria: May 19, 2008
• First Posted (Estimate): May 21, 2008

Study Record Updates

• Last Update Posted (Estimate): December 9, 2010
• Last Update Submitted That Met QC Criteria: December 7, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Phase I
• Other Study ID Numbers: D1140C00002