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
Overview
- Phase
- Phase 1
- Intervention
- AZD7325
- Conditions
- Healthy
- Sponsor
- AstraZeneca
- Enrollment
- 48
- Primary Endpoint
- 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.
- Status
- Terminated
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Low dose or placebo, twice daily
Intervention: AZD7325
1
Low dose or placebo, twice daily
Intervention: Placebo
2
Low dose or placebo, once daily
Intervention: AZD7325
2
Low dose or placebo, once daily
Intervention: Placebo
3
Middle dose or placebo, twice daily
Intervention: AZD7325
3
Middle dose or placebo, twice daily
Intervention: Placebo
4
High dose or placebo, once daily
Intervention: AZD7325
4
High dose or placebo, once daily
Intervention: Placebo
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.(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.)