Pharmacokinetics of SP-104

NCT05002946 | Completed Phase 1 FDA Drug

• 1 other identifier: SP-104-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Concentration of SP-104

  Observed plasma concentrations of naltrexone and metabolite 6β-naltrexol ng/mL

  72 hours

• Time to maximum concentration of naltrexone and metabolite 6β-naltrexol

  Time to maximum plasma concentration of naltrexone and metabolite 6β-naltrexol in minutes

  72 hours

Study Arms (3)

A: SP-104 Fasting

EXPERIMENTAL

Oral administration of SP-104 under fasting conditions

Drug: SP-104

B: SP-104 Under Fed Conditions

EXPERIMENTAL

Oral administration of SP-104 under fed conditions

Drug: SP-104

Naltrexone Hydrochloride Tablets Fasting

ACTIVE COMPARATOR

Oral administration of Naltrexone Hydrochloride Tablets, 50 mg USP under fasting

Drug: Naltrexone Hydrochloride 50Mg Oral Tablet

Interventions

SP-104 DRUG

single oral dose

A: SP-104 Fasting; B: SP-104 Under Fed Conditions

Naltrexone Hydrochloride 50Mg Oral Tablet DRUG

single oral dose

Naltrexone Hydrochloride Tablets Fasting

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 abstinence from heterosexual intercourse, from screening through until at least 30 days after the last study dose, or to the use of an effective method of contraception from screening through until at least 30 days after the last study dose.
• Able to swallow capsules and tablets.

You may not qualify if:

• Subject has a history of clinically significant disease, including cardiovascular, GI, renal, hepatic, pulmonary, endocrine, hematologic, vascular, immunologic, metabolic, or collagen disease.
• History of drug or alcohol abuse or dependence based on the DSM-IV criteria as reported by the subject or known to the Investigator.
• Subjects currently dependent on opioids, including those currently maintained on opiate agonists or partial agonists.
• Subjects in acute opioid withdrawal.
• Use of any other investigational drug within 30 days or 6 half-lives, whichever is longer, prior to Day 1 of Period 1.
• Use of prescription medications including opioids, or natural food supplements, alcohol, grapefruit juice, or caffeine within study-specified timeframes.
• Positive urine drug screen for alcohol and drugs of abuse.
• History of allergic or adverse response to naltrexone.
• Serology positive for hepatitis B surface antigen, hepatitis C antibodies, or HIV antibodies.
• Subjects with current or past SARS-CoV-2 infection.
• Are smokers, 'and any use of other types of tobacco or nicotine products within six months prior to Day 1 of Period 1.
• Have donated plasma within 7 days prior Day 1 of Period 1.
• Have donated or lost whole blood prior to administration of the study medication as follows: 50 to 499 mL of whole blood within 30 days, or more than 499 mL of whole within the last 56 days prior to drug administration.
• Have had a serious illness in the 4 weeks preceding the Screening Visit that resulted in missed work or hospitalization (note: subjects missing work due to non-serious illness is not excluded).
• Acute illness, especially any infection, within 4 weeks prior to Day 1 of Period 1.

Sponsors & Collaborators

• Scilex Pharmaceuticals, Inc.: lead

Study Sites (1)

Christchurch Clinical Studies Trust (NZCR)

Christchurch, 8011, New Zealand

Location

MeSH Terms

Interventions

Dronabinol; Naltrexone; Tablets

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Dmitri Lissin, MD

  Scilex Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects randomized to Treatment A will fast at least 10 hours prior to and for at least 4 hours following dosing and will be treated with a single dose of SP-104. Subjects randomized to Treatment B will be fed a high-fat breakfast 30 minutes prior to dosing, SP-104 will be administered 30 minutes after start of the meal. No food will be allowed for at least 4 hours after the dose. Subjects randomized to Treatment C will fast at least 10 hours prior to and for at least 4 hours following dosing and will be treated with a single dose of Naltrexone Hydrochloride Tablet. Subjects will crossover to each treatment after a wash out period.

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 12, 2021
• Study Start: January 11, 2022
• Primary Completion: April 24, 2022
• Study Completion: April 24, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)