AZD7325 Japan Multiple Ascending Dose (MAD) Study

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: AZD7325; Drug: Placebo

• Registration Number: NCT00945425
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Study Completion: 2009-11
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-15
• Last Update Posted: 2011-02-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD7325	Low dose or placebo, twice daily
1	Placebo	Low dose or placebo, twice daily
2	AZD7325	Low dose or placebo, once daily
2	Placebo	Low dose or placebo, once daily
3	AZD7325	Middle dose or placebo, twice daily
3	Placebo	Middle dose or placebo, twice daily
4	AZD7325	High dose or placebo, once daily
4	Placebo	High dose or placebo, once daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.