- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04958876
Study to Evaluate the Safety of SP-104
January 28, 2022 updated by: Scilex Pharmaceuticals, Inc.
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
Evaluate the safety and tolerability of 3-day repeat-dose of SP-104 compared to naltrexone hydrochloride immediate release.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Auckland, New Zealand, 1010
- Auckland Clinical Studies (NZCR)
-
Christchurch, New Zealand, 8011
- Christchurch Clinical Studies Trust (NZCR)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SP-104 crossover to naltrexone immediate release
SP-104 administration followed by a crossover to naltrexone immediate release oral capsule administration
|
oral capsule once daily
oral capsule once daily
|
Experimental: Naltrexone immediate release crossover to SP-104
Naltrexone immediate release oral capsule administration with a crossover to SP-104 administration
|
oral capsule once daily
oral capsule once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of treatment emergent adverse events
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 4, 2021
Primary Completion (Actual)
December 20, 2021
Study Completion (Actual)
December 20, 2021
Study Registration Dates
First Submitted
July 6, 2021
First Submitted That Met QC Criteria
July 6, 2021
First Posted (Actual)
July 12, 2021
Study Record Updates
Last Update Posted (Actual)
January 31, 2022
Last Update Submitted That Met QC Criteria
January 28, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP-104-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on SP-104
-
Aviceda Therapeutics, Inc.TerminatedDiabetic Retinopathy | Diabetic Macular EdemaUnited States
-
Fotona d.o.o.UnknownStress Urinary IncontinenceCanada
-
ACADIA Pharmaceuticals Inc.Completed
-
Otonomy, Inc.Completed
-
L&C BioPROMeDisRecruitingHerniation, DiscKorea, Republic of
-
Aviceda Therapeutics, Inc.RecruitingMacular Degeneration | Geographic Atrophy of the MaculaUnited States
-
Addpharma Inc.Recruiting
-
Akesobio Australia Pty LtdUnknown
-
AlizymeCompleted