AZD7325 Japan Multiple Ascending Dose (MAD) Study

Phase 1TerminatedNCT00945425

AstraZeneca48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

AZD7325DRUG

oral capsule, once or twice daily, 7 days

PlaceboDRUG

oral capsule, once or twice daily, 7 days

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Observations/Assessments are made at each visit (Screening visit, Treatment visit (Day 1-Day 9) and Follow-up visit).

Secondary Outcomes

To evaluate and characterize the pharmacokinetics of AZD7325 when given orally in multiple ascending doses by assessment of drug concentration in plasma and urine.

Time frame: 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).

Time frame: Observations/Assessments are made during the treatment visit.

Data from ClinicalTrials.gov

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