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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05002946




Registration number
NCT05002946
Ethics application status
Date submitted
5/08/2021
Date registered
12/08/2021
Date last updated
3/05/2022

Titles & IDs
Public title
Pharmacokinetics of SP-104
Scientific title
Phase 1, Open Label, Randomized, Single-dose, 3-Period, 3-Treatment Crossover Study to Evaluate the Pharmacokinetics of SP-104 Under Fasting and Fed Conditions and to Compare to Naltrexone Hydrochloride Tablets USP in Healthy Adult Subjects
Secondary ID [1] 0 0
SP-104-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SP-104
Treatment: Drugs - Naltrexone Hydrochloride 50Mg Oral Tablet

Experimental: A: SP-104 Fasting - Oral administration of SP-104 under fasting conditions

Experimental: B: SP-104 Under Fed Conditions - Oral administration of SP-104 under fed conditions

Active Comparator: Naltrexone Hydrochloride Tablets Fasting - Oral administration of Naltrexone Hydrochloride Tablets, 50 mg USP under fasting


Treatment: Drugs: SP-104
single oral dose

Treatment: Drugs: Naltrexone Hydrochloride 50Mg Oral Tablet
single oral dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Concentration of SP-104
Timepoint [1] 0 0
72 hours
Primary outcome [2] 0 0
Time to maximum concentration of naltrexone and metabolite 6ß-naltrexol
Timepoint [2] 0 0
72 hours

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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.

- Subjects with GFR <90 mL/min at Screening .

- Subjects with any elevation of liver function tests .

- Hemoglobin <12.0 g/dL for males or <10.0 g/dL for females .

- Subjects with a CK value of greater than the upper limit of normal that is not
explainable by exercise and that does not come back to reference range upon retest.

- Any history of cancer or any active malignancy except for successfully treated basal
cell carcinoma or squamous cell carcinoma.

- Subjects with reported history of, or current treatment for, GI disease such as
diverticulitis, diverticulosis, irritable bowel diseases, ulcer, inflammatory bowel
disease or history of conditions, such as abdominal gunshot wounds.

- Are an employee, family member, Sponsor, or student of the Investigator or of the
clinical site.

- Clinical judgment by the investigator that the subject should not participate in the
study.

Study design
Purpose of the study
Basic Science
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
Open (masking not used)
Who is / are masked / blinded?



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
11/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/04/2022
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05002946
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dmitri Lissin, MD
Address 0 0
Scilex Pharmaceuticals, Inc.
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