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 developed by Scilex Holding Company. It is a Phase 1 candidate that has been studied in healthy volunteers. Its specific therapeutic indications have not been publicly disclosed, and it remains in early clinical development.
SP-104 targets opioid receptors. It is a small molecule designed to act on this receptor class. Targeting opioid receptors places SP-104 within a well-established pharmacological family, though its precise clinical applications are still being evaluated in early-stage research.
SP-104 is being developed by Scilex Holding Company, which trades under the ticker SCLX. The company is the sponsor of the clinical program evaluating the drug. Scilex is a biopharmaceutical company focused on developing and commercializing therapies, and SP-104 is one of its investigational assets.
SP-104 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, and no active trials are currently listed for this candidate.
SP-104 has been evaluated in two completed Phase 1 trials. NCT05002946 assessed the pharmacokinetics of SP-104 in 18 healthy volunteers in New Zealand. NCT04958876 evaluated the safety of SP-104 in 52 healthy volunteers, also in New Zealand. Both trials enrolled adults aged 18 and older.
Across the two completed Phase 1 trials, 70 participants have been enrolled. NCT05002946 enrolled 18 healthy volunteers, and NCT04958876 enrolled 52 healthy volunteers. Both studies were randomized, double-blind, and controlled, and were conducted in New Zealand with adults aged 18 years and older.