NCT04958876

Study to Evaluate the Safety of SP-104

Phase 1, Double-blind, Randomized, 2-Period, 2-Treatment Crossover Study to Evaluate the Safety of SP-104 Compared to Immediate Release Naltrexone Capsules in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Scilex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Evaluate the safety and tolerability of 3-day repeat-dose of SP-104 compared to naltrexone hydrochloride immediate release.

Detailed description

The purpose of this trial is to evaluate the safety and tolerability of SP-104 relative to naltrexone immediate release capsules in healthy adults. The study is designed to test the hypothesis that the formulation of SP-104 will mitigate against adverse events associated with naltrexone.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	SP-104	oral capsule once daily
DRUG	Naltrexone immediate release oral capsules	oral capsule once daily

Timeline

• Start date: 2021-10-04
• Primary completion: 2021-12-20
• Completion: 2021-12-20
• First posted: 2021-07-12
• Last updated: 2022-01-31

Locations

2 sites across 1 country: New Zealand