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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Safety, tolerability, and pharmacokinetics will be assessed throughout the study. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.
This is a randomized, double-blind, placebo-controlled, parallel group SAD study conducted at one study center. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.
Safety (i.e., adverse events [AEs], physical examinations, pulse oximetry, vital signs, orthostatic vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory tests, Columbia suicide severity rating scale [C-SSRS], and Mini-Mental State Examination [MMSE]) will be assessed throughout the study. Blood samples will be collected through 48 hours post-dose for the PK assessment of XC130-A10H and the metabolites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XC130-A10H | Experimental | XC130-A10H (single dose) |
|
| Placebo | Placebo Comparator | placebo (single dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XC130-A10H | Drug | XC130-A10H supplied as a 0.2, 0.4, 0.8, 1.6 or 3.2 mg dose, administered in capsules or tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Adverse Events | Adverse Events will be monitored throughout confinement in the clinic and through the 14-day follow-up visit. | pre-dose through 14 days post-dose |
| Changes from baseline in systolic and diastolic blood pressure | Blood pressure (systolic and diastolic) will be measured pre-dose and throughout the study at the time points specified and compared to baseline. | pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration [Cmax] of XC13-A10H | Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the maximum observed concentration for XC130-A10H and primary metabolite will be calculated. | 48 hours |
| Area under the curve [AUC] of XC130-A10H |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Fishman, MD | Xoc Consulting Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Double-blind
| Placebo | Drug | Placebo supplied as matching capsules or tablets |
|
Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the area under the concentration-time curve, from time 0 to the last observed non-zero concentration will be calculated for XC130-A10H and primary metabolite. |
| 48 hours |
| Time to reach the maximum plasma concentration [Tmax] of XC130-A10H | Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, and 48 hours post-dose and the time to reach the maximum plasma concentration of XC130-A10H and primary metabolite will be calculated. | 48 hours |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |