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The purpose of this study is to characterize the absorption, metabolism and routes of excretion of RE104 and its metabolites in healthy volunteers. This study will quantify drug and metabolites in blood, urine, and feces samples collected before study drug administration and through at least 168 hours after SC dosing of [14C]-RE104.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 mg 2-[14C]-RE104 (1uCi/30mg) | Experimental | A single subcutaneous injection of 30 mg 2-[14C]-RE104 for Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-[14C]-RE104 for Injection | Drug | Single, subcutaneous dose of 2-[14C]-RE104 for Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total excreted radioactivity (Ae) | Through 168 hours postdose | |
| Cumulative recovery of total excreted radioactivity (CUM Ae) | Through 168 hours postdose | |
| Area under the concentration-time curve (AUC) for RE104 and 4-OH-DiPT | Through 168 hours postdose | |
| Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT | Through 168 hours postdose | |
| Time to reach Cmax (Tmax) for RE104 and 4-OH-DiPT | Through 168 hours postdose | |
| Terminal half-life (t1/2) of RE104 and 4-OH-DiPT | Through 168 hours postdose | |
| Apparent terminal elimination half-life (λz) for RE104 and 4-OH-DiPT | Through 168 hours postdose | |
| Mean residence time (MRT) | Through 168 hours postdose | |
| Apparent total body clearance (CL/F) for RE104 | Through 168 hours postdose | |
| Apparent volume of distribution during the terminal phase (Vz/F) for RE104 | Through 168 hours postdose | |
| Total metabolite profiling with description of relevant PK parameters and structural identification of major metabolites present in all matrices |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness | A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug. | From dosing (Day 0) through study completion (Day 7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Pollack, Chief Medical Officer | Reunion Neuroscience Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Inc. | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Through 168 hours postdose |