Study to Evaluate the Safety of SP-104

NCT04958876 | Completed Phase 1

• 1 other identifier: SP-104-02
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment emergent adverse events

  1 week

Study Arms (2)

SP-104 crossover to naltrexone immediate release

EXPERIMENTAL

SP-104 administration followed by a crossover to naltrexone immediate release oral capsule administration

Drug: SP-104; Drug: Naltrexone immediate release oral capsules

Naltrexone immediate release crossover to SP-104

EXPERIMENTAL

Naltrexone immediate release oral capsule administration with a crossover to SP-104 administration

Drug: SP-104; Drug: Naltrexone immediate release oral capsules

Interventions

SP-104 DRUG

oral capsule once daily

Naltrexone immediate release crossover to SP-104; SP-104 crossover to naltrexone immediate release

Naltrexone immediate release oral capsules DRUG

oral capsule once daily

Naltrexone immediate release crossover to SP-104; SP-104 crossover to naltrexone immediate release

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to read, write, and understand the English language and provide English language written informed consent (IC) prior to beginning any study procedures.
• Male or female age 18 to 70 years (inclusive) at screening.
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiogram (ECG), as deemed by the Investigator.
• Negative urine drug screen for drugs of abuse, including cocaine, marijuana, amphetamines, and barbiturates at the Screening Visit and at each check-in.
• If female, heterosexually active, of childbearing potential, not pregnant, not trying to become pregnant, or lactating, individuals are eligible to participate if participants 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 listed below, from screening through until at least 30 days after the last study dose. A second non-hormonal method of contraception is required if a hormonal form of birth control is used. Females of childbearing potential must have negative pregnancy tests at Screening and on admission.
• If male and heterosexually active, individuals are eligible to participate if participants agree to total abstinence from heterosexual intercourse, from screening through until at least 90 days after the last study dose, or to the use of an effective method listed below, from screening through until at least 90 days after the last study dose.
• Able to swallow capsules.
• Agrees to comply with all study requirements throughout the entire study period.

You may not qualify if:

• A body mass index (BMI) \<18 kg/m2 or \>30 kg/m2 (without rounding).
• Are using prescription medications or over-the-counter products (including dietary supplements such as vitamins, minerals, herbs or other botanicals, amino acids, enzymes (extracts or concentrates), or probiotics (bacteria or yeasts), within 14 days prior to administration of the study medication.
• Currently using or have recently used opioids
• Use of any other investigational drug within 30 days prior to administration of the study medication.
• History of allergic or adverse response to naltrexone.
• History of drug or alcohol abuse (\>80 g/day).
• History of sleep apnea or restless leg syndrome.
• Serology positive for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV) antibodies.
• Positive for known disease (e.g., corona virus disease 2019 (COVID-19 )).
• Subjects with current or past SARS-CoV-2 infection, if tested according to local requirements.
• Have had a serious illness in the 4 weeks preceding the Screening Visit that resulted in missed work or hospitalization (note: missed work in itself may not denote serious illness).
• Have cancer within the past 5 years (treated or untreated).
• Are females who are pregnant, plan to become pregnant during the study, or are breastfeeding.
• Are an employee, family member, sponsor, or student of the Investigator or of the clinical site.
• Are unable to understand or adhere to the requirements of the protocol.

Sponsors & Collaborators

• Scilex Pharmaceuticals, Inc.: lead

Study Sites (2)

Auckland Clinical Studies (NZCR)

Auckland, 1010, New Zealand

Location

Christchurch Clinical Studies Trust (NZCR)

Christchurch, 8011, New Zealand

Location

MeSH Terms

Interventions

Dronabinol; Naltrexone

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 12, 2021
• Study Start: October 4, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2)