MedTrace Logo

Pharmacokinetics of SP-104

NCT05002946 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-05-03

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

SP-104

single oral dose

DRUG

Naltrexone Hydrochloride 50Mg Oral Tablet

single oral dose

Sponsors & Collaborators

  • Scilex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Dmitri Lissin, MD · Scilex Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2022-04-24
Completion
2022-04-24
FDA Drug
Yes

Countries

  • New Zealand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05002946 on ClinicalTrials.gov