AZD7325 Japan Multiple Ascending Dose (MAD) Study (JMAD)

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 Japanese Subjects

The purpose of this study is to evaluate the safety and tolerability after repeated ascending doses of AZD7325 in Japanese healthy male subjects.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD7325; Drug: Placebo

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Japanese subjects

Exclusion Criteria:

• Significant illness, as judged by the investigator, within 2 weeks of Day 1
• Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit
• Blood loss in excess of 200 mL within 30 days of Day 1, in excess of 400 mL within 90 days of Day 1, or in excess of 1200 mL within 1 year of Day 1
• Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Low dose or placebo, twice daily	Drug: AZD7325; oral capsule, once or twice daily, 7 days; Drug: Placebo; oral capsule, once or twice daily, 7 days
Experimental: 2; Low dose or placebo, once daily	Drug: AZD7325; oral capsule, once or twice daily, 7 days; Drug: Placebo; oral capsule, once or twice daily, 7 days
Experimental: 3; Middle dose or placebo, twice daily	Drug: AZD7325; oral capsule, once or twice daily, 7 days; Drug: Placebo; oral capsule, once or twice daily, 7 days
Experimental: 4; High dose or placebo, once daily	Drug: AZD7325; oral capsule, once or twice daily, 7 days; Drug: Placebo; oral capsule, once or twice daily, 7 days

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 in healthy male Japanese subjects by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEG.	Observations/Assessments are made at each visit (Screening visit, Treatment visit (Day 1-Day 9) and Follow-up visit).

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate and characterize the pharmacokinetics of AZD7325 when given orally in multiple ascending doses by assessment of drug concentration in plasma and urine.	Blood and urine samples will be taken before and after study drug administration (up to 48 hours post dose).
To evaluate the effects on VAS, Ataxia assessments and CogState Battery (cognition).	Observations/Assessments are made during the treatment visit.

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Study Completion (Anticipated): November 1, 2009

Study Registration Dates

• First Submitted: July 23, 2009
• First Submitted That Met QC Criteria: July 23, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Estimate): February 16, 2011
• Last Update Submitted That Met QC Criteria: February 15, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Phase I; Volunteer
• Other Study ID Numbers: D1140C00015