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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04958876




Registration number
NCT04958876
Ethics application status
Date submitted
6/07/2021
Date registered
12/07/2021
Date last updated
31/01/2022

Titles & IDs
Public title
Study to Evaluate the Safety of SP-104
Scientific title
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
Secondary ID [1] 0 0
SP-104-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SP-104
Treatment: Drugs - Naltrexone immediate release oral capsules

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

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


Treatment: Drugs: SP-104
oral capsule once daily

Treatment: Drugs: Naltrexone immediate release oral capsules
oral capsule once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment emergent adverse events
Timepoint [1] 0 0
1 week

Eligibility
Key inclusion criteria
1. 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.
2. Male or female age 18 to 70 years (inclusive) at screening.
3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiogram (ECG), as deemed by the Investigator.
4. Negative urine drug screen for drugs of abuse, including cocaine, marijuana, amphetamines, and barbiturates at the Screening Visit and at each check-in.
5. 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.
6. 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.
7. Able to swallow capsules.
8. Agrees to comply with all study requirements throughout the entire study period.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. A body mass index (BMI) <18 kg/m2 or >30 kg/m2 (without rounding).
2. 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.
3. Currently using or have recently used opioids
4. Use of any other investigational drug within 30 days prior to administration of the study medication.
5. History of allergic or adverse response to naltrexone.
6. History of drug or alcohol abuse (>80 g/day).
7. History of sleep apnea or restless leg syndrome.
8. Serology positive for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV) antibodies.
9. Positive for known disease (e.g., corona virus disease 2019 (COVID-19 )).
10. Subjects with current or past SARS-CoV-2 infection, if tested according to local requirements.
11. 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).
12. Have cancer within the past 5 years (treated or untreated).
13. Are females who are pregnant, plan to become pregnant during the study, or are breastfeeding.
14. Are an employee, family member, sponsor, or student of the Investigator or of the clinical site.
15. Are unable to understand or adhere to the requirements of the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2021
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Scilex Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Evaluate the safety and tolerability of 3-day repeat-dose of SP-104 compared to naltrexone hydrochloride immediate release.
Trial website
https://clinicaltrials.gov/study/NCT04958876
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04958876