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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04958876 | Study to Evaluate the Safety of SP-104 | PHASE1 | COMPLETED | 52 | — | — | Oct 4, 2021 | Dec 20, 2021 | Jan 31, 2022 | 2 | New Zealand |
| Arm | Type | Description |
|---|---|---|
| SP-104 crossover to naltrexone immediate release | EXPERIMENTAL | SP-104 administration followed by a crossover to naltrexone immediate release oral capsule administration |
| Naltrexone immediate release crossover to SP-104 | EXPERIMENTAL | Naltrexone immediate release oral capsule administration with a crossover to SP-104 administration |
| Name | Type | Description |
|---|---|---|
| SP-104 | DRUG | oral capsule once daily |
| Naltrexone immediate release oral capsules | DRUG | oral capsule once daily |
Inclusion Criteria: 1. Able and willing to read, write, and understand the English language and provide English language written informed consent (IC) prior to beginning any study procedures. 2. Male or female age 18 to 70 years (inclusive) at screening. 3. Medically healthy with no clinically sign...