AZD7325 Japan Multiple Ascending Dose (MAD) Study

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD7325
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, Volunteer