HealthyPhase 1NCT05002946
Pharmacokinetics of SP-104
A Phase 1 study testing SP-104 and Naltrexone Hydrochloride 50Mg Oral Tablet in people with Healthy, run by Scilex Pharmaceuticals, Inc. at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SP-104 and Naltrexone Hydrochloride 50Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNew Zealand
- Study dates
- 11 Jan 2022to 24 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Christchurch Clinical Studies Trust (NZCR)
Christchurch, 8011
About this study
Official 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
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.
Read the detailed description
The study will characterize the single-dose pharmacokinetics of naltrexone and metabolite (6 Beta-naltrexol) following administration of SP-104 compared to Naltrexone Hydrochloride Tablets, USP, 50 mg in healthy adult subjects under fasting conditions. The study will also characterize the effect of food intake on the pharmacokinetics of SP-104 in healthy adult subjects. Additionally, the safety and tolerability of single doses of SP-104 under fed and fasting conditions will be characterized.
- Conditions
- Healthy
- Being tested
- SP-104, Naltrexone Hydrochloride 50Mg Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-104Drug
single oral dose
Naltrexone Hydrochloride 50Mg Oral TabletDrug
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| A: SP-104 Fasting | Experimental | Oral administration of SP-104 under fasting conditions Receives: Drug: SP-104 |
| B: SP-104 Under Fed Conditions | Experimental | Oral administration of SP-104 under fed conditions Receives: Drug: SP-104 |
| Naltrexone Hydrochloride Tablets Fasting | Active comparator | Oral administration of Naltrexone Hydrochloride Tablets, 50 mg USP under fasting Receives: Drug: Naltrexone Hydrochloride 50Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of SP-104
Observed plasma concentrations of naltrexone and metabolite 6β-naltrexol ng/mL
Measured: 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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start11 Jan 2022
- Primary completion24 Apr 2022
- Study completion24 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scilex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dmitri Lissin, MD, Study director, Scilex Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002946
- Sponsor's protocol ID
- SP-104-01
- Status last verified
- Apr 2022
- First submitted
- 5 Aug 2021
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05002946
- Acronym / sponsor ID
- SP-104-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Scilex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 24 Apr 2022 (actual)
- Study completion
- 24 Apr 2022 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will characterize the single-dose pharmacokinetics of naltrexone and metabolite (6 Beta-naltrexol) following administration of SP-104 compared to Naltrexone Hydrochloride Tablets, USP, 50 mg in healthy adult subjects under fasting conditions. The study will also characterize the effect of food intake on the pharmacokinetics of SP-104 in healthy adult subjects. Additionally, the safety and tolerability of single doses of SP-104 under fed and fasting conditions will be characterized.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| A: SP-104 Fasting | Experimental | Drug: SP-104Oral administration of SP-104 under fasting conditions |
| B: SP-104 Under Fed Conditions | Experimental | Drug: SP-104Oral administration of SP-104 under fed conditions |
| Naltrexone Hydrochloride Tablets Fasting | Active comparator | Drug: Naltrexone Hydrochloride 50Mg Oral TabletOral administration of Naltrexone Hydrochloride Tablets, 50 mg USP under fasting |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP-104single oral dose | Drug | A: SP-104 Fasting, B: SP-104 Under Fed Conditions |
| Naltrexone Hydrochloride 50Mg Oral Tabletsingle oral dose | Drug | Naltrexone Hydrochloride Tablets Fasting |
Primary outcome
Concentration of SP-104
Time frame: 72 hours
Observed plasma concentrations of naltrexone and metabolite 6β-naltrexol ng/mL
Time to maximum concentration of naltrexone and metabolite 6β-naltrexol
Time frame: 72 hours
Time to maximum plasma concentration of naltrexone and metabolite 6β-naltrexol in minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitri Lissin, MD study director
Scilex Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SP-104 and Naltrexone Hydrochloride 50Mg Oral Tablet in people with Healthy, run by Scilex Pharmaceuticals, Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of SP-104 (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.