Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SP-104 · 2 trials · 2 indications
Observed plasma concentrations of naltrexone and metabolite 6β-naltrexol ng/mL
Time to maximum plasma concentration of naltrexone and metabolite 6β-naltrexol in minutes
| Arm | Type | Description |
|---|---|---|
| A: SP-104 Fasting | EXPERIMENTAL | Oral administration of SP-104 under fasting conditions |
| B: SP-104 Under Fed Conditions | EXPERIMENTAL | Oral administration of SP-104 under fed conditions |
| Naltrexone Hydrochloride Tablets Fasting | ACTIVE_COMPARATOR | Oral administration of Naltrexone Hydrochloride Tablets, 50 mg USP under fasting |
| 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 | single oral dose |
| Naltrexone Hydrochloride 50Mg Oral Tablet | DRUG | single oral dose |
| Naltrexone immediate release oral capsules | DRUG | oral capsule once daily |
Inclusion Criteria: * Provide informed consent , can understand and comply with the requirements of the study, and are able to communicate with the investigator. * male and female adult subjects between 18 and 65 years. * Body mass index (BMI) of 18-32 kg/m2. * Medically healthy * Agree to total ab...
SP-104 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with trials evaluating its safety and pharmacokinetics. The drug is not approved for any condition and remains in early-stage clinical testing.
SP-104 is being developed by Scilex Holding Company, which trades under the ticker SCLX. The company is conducting Phase 1 clinical trials of this investigational small molecule in healthy volunteers.
SP-104 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy volunteers.
SP-104 has been studied in two completed Phase 1 trials. NCT04958876 evaluated the safety of SP-104 in 52 healthy volunteers in New Zealand. NCT05002946 assessed the pharmacokinetics of SP-104 in 18 healthy participants, also in New Zealand.
SP-104 is not FDA approved. It is an investigational small molecule currently in Phase 1 clinical development. The completed trials have focused on safety and pharmacokinetics in healthy volunteers, and the drug has not yet progressed to later-stage studies or regulatory approval.