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To evaluate the safety and tolerability of single ascending doses of zelquistinel in normal human volunteers
Single ascending dose (SAD), double-blind placebo-controlled study in normal human volunteers.
Secondary objectives:
To evaluate the pharmacokinetics (PK) and eeg biomarker of target engagement of zelquistinel following increasing single doses of zelquistinel.
Zelquistinel or Placebo: Dose/Mode of Administration: Single dose; oral
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 microgram zelquistinel | Experimental | zelquistinel, 100 microgram tablet, PO, Single Dose with 28 day follow up |
|
| 1 mg zelquistinel | Experimental | zelquistinel, 1 mg tablet, PO, Single Dose with 28 day follow up |
|
| 3 mg zelquistinel | Experimental | zelquistinel, 3 mg tablet, PO, Single Dose with 28 day follow up |
|
| 10 mg zelquistinel | Experimental | zelquistinel, 10 mg tablet, PO, Single Dose with 28 day follow up |
|
| 25 mg zelquistinel | Experimental | zelquistinel, 25 mg tablet, PO, Single Dose with 28 day follow up |
|
| 50 mg zelquistinel | Experimental | zelquistinel, 50 mg tablet, PO, Single Dose with 28 day follow up |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zelquistinel | Drug | Single dose of zelquistinel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment emergent adverse events | through study completion | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics, maximum plasma concentration | maximum plasma concentration | 24 hours |
| Pharmacokinetics, time to maximum plasma concentration | time to maximum plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Koenig, MD | Syndeio Biosciences | Study Chair |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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Double blind placebo controlled
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Triple blind
|
| 100 mg zelquistinel | Experimental | zelquistinel, 100 mg tablet, PO, Single Dose with 28 day follow up |
|
| 1 mg zelquistinel with CSF collection | Experimental | zelquistinel, 1 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection |
|
| 10 mg zelquistinel with CSF collection | Experimental | zelquistinel, 10 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection |
|
| Placebo | Placebo Comparator | Placebo tablet, PO, Single Dose with 28 day follow up |
|
| Placebo | Drug | Placebo |
|
| 24 hours |
| Pharmacokinetics, area under the curve for plasma concentration | area under the curve, plasma calculated 0-infinity | 72 hours |