NCT05002946

Pharmacokinetics of SP-104

Phase 1, Open Label, Randomized, Single-dose, 3-Period, 3-Treatment Crossover Study to Evaluate the Pharmacokinetics of SP-104 Under Fasting and Fed Conditions and to Compare to Naltrexone Hydrochloride Tablets USP in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Scilex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This open-label, 3-period, 3-treatment, randomized study will characterize the pharmacokinetics and safety and tolerability of SP-104 under fasting and fed conditions as compared to the pharmacokinetics of Naltrexone Hydrochloride Tablets, USP, 50 mg in healthy adult subjects.

Detailed description

The study will characterize the single-dose pharmacokinetics of naltrexone and metabolite (6 Beta-naltrexol) following administration of SP-104 compared to Naltrexone Hydrochloride Tablets, USP, 50 mg in healthy adult subjects under fasting conditions. The study will also characterize the effect of food intake on the pharmacokinetics of SP-104 in healthy adult subjects. Additionally, the safety and tolerability of single doses of SP-104 under fed and fasting conditions will be characterized.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SP-104	single oral dose
DRUG	Naltrexone Hydrochloride 50Mg Oral Tablet	single oral dose

Timeline

• Start date: 2022-01-11
• Primary completion: 2022-04-24
• Completion: 2022-04-24
• First posted: 2021-08-12
• Last updated: 2022-05-03

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study