Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02023606 | Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M | PHASE1 | COMPLETED | 7 | — | — | Nov 1, 2013 | Dec 1, 2013 | May 13, 2016 | 1 | United Kingdom |
C(urine and feces), Ae(urine and feces), CumAe(urine and feces), % Dose(urine and feces), CUM% Dose(urine and feces).
| Arm | Type | Description |
|---|---|---|
| SPN-810M | EXPERIMENTAL | Single dose of 20 mL solution containing 50 mg of SPN-810M and no less than 8.5 MBq (225 µCi) carbon-14 (14C)-SPN-810M, and no more than 11.3 MBq (305 µCi) \[14C\] SPN-810M. |
| Name | Type | Description |
|---|---|---|
| SPN-810M | DRUG | - |
Key Entry: 1. Healthy males. 2. Aged 30 to 55 years. 3. Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, urinalysis, vital signs, and electrocardiogram. 4. Able to voluntarily provide written informed consent to par...