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Decided to stop development of this compound globally
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Low dose or placebo, twice daily |
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| 2 | Experimental | Low dose or placebo, once daily |
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| 3 | Experimental | Middle dose or placebo, twice daily |
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| 4 | Experimental | High dose or placebo, once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7325 | Drug | oral capsule, once or twice daily, 7 days |
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| 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). |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuji Kumagai, MD, PhD | Kitasato University East Hospital, Kanagawa, Japan | Principal Investigator |
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| ID | Term |
|---|---|
| C576237 | 4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide |
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| Placebo | Drug | oral capsule, once or twice daily, 7 days |
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| Observations/Assessments are made during the treatment visit. |