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This is an open-label, single-arm, multiple ascending dose Phase I study to assess the dose- and concentration-dependent displacement of [18F]MNI-659 [a PET tracer targeting phosphodiesterase 10 (PDE10)] by EVP-6308.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVP-6308; Arm 1 | Experimental | low dose, Capsule, Twice Daily, Day 1 through Day 3 |
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| EVP-6308; Arm 2 | Experimental | low intermediate dose, Capsule, Twice Daily, Day 1 through Day 3 |
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| EVP-6308; Arm 3 | Experimental | high intermediate dose, Capsule, Once Daily, Day 1 through Day 3 |
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| EVP-6308; Arm 4 | Experimental | high dose, Capsule, Once Daily, Day 1 through Day 3 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVP-6308 | Drug | Arms 1, 2, 3, 4 |
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| Measure | Description | Time Frame |
|---|---|---|
| Target occupancy of [18F]MNI-659. | Change in binding potential. | Baseline and Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of EVP-6308 as assessed by adverse events, vital signs, clinical laboratory tests, C-SSRS, and electrocardiogram (ECG). | The following will be evaluated: clinical laboratory evaluations (chemistry, hematology, coagulation and urinalysis), physical examination, directed neurological examination, vital signs, orthostatic blood pressure, 12-lead ECG, and assessment for suicidality. Adverse events and concomitant medications will be collected from the time of signing the informed consent. |
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Inclusion Criteria:
• Healthy male or female volunteers, 18 to 50 years of age
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven | Connecticut | United States |
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| Baseline to Day 4 or Early Termination |
| Pharmacokinetics of EVP-6308 and EVP-6308 N-oxide. | Pharmacokinetic parameters to be determined include Cmax, Tmax, t1/2, and CL/F. | Day 3 |