Healthy VolunteersPhase 1NCT04958876
Study to Evaluate the Safety of SP-104
A Phase 1 study testing SP-104 and Naltrexone immediate release oral capsules in people with Healthy Volunteers, run by Scilex Pharmaceuticals, Inc. at 2 sites in New Zealand.
Trial summary
Evaluate the safety and tolerability of 3-day repeat-dose of SP-104 compared to naltrexone hydrochloride immediate release. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SP-104 and Naltrexone immediate release oral capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 4 Oct 2021to 20 Dec 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Auckland Clinical Studies (NZCR)
Auckland, 1010
Christchurch Clinical Studies Trust (NZCR)
Christchurch, 8011
About this study
Official 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
Evaluate the safety and tolerability of 3-day repeat-dose of SP-104 compared to naltrexone hydrochloride immediate release.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- SP-104, Naltrexone immediate release oral capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-104Drug
oral capsule once daily
Naltrexone immediate release oral capsulesDrug
oral capsule once daily
| Study group | Role | What they receive |
|---|---|---|
| SP-104 crossover to naltrexone immediate release | Experimental | SP-104 administration followed by a crossover to naltrexone immediate release oral capsule administration Receives: 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 Receives: Drug: SP-104; Drug: Naltrexone immediate release oral capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start4 Oct 2021
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scilex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958876
- Sponsor's protocol ID
- SP-104-02
- Status last verified
- Jan 2022
- First submitted
- 6 Jul 2021
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04958876
- Acronym / sponsor ID
- SP-104-02
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Scilex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 12 Jul 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.
Evaluate the safety and tolerability of 3-day repeat-dose of SP-104 compared to naltrexone hydrochloride immediate release.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP-104 crossover to naltrexone immediate release | Experimental | Drug: SP-104, Drug: Naltrexone immediate release oral capsulesSP-104 administration followed by a crossover to naltrexone immediate release oral capsule administration |
| Naltrexone immediate release crossover to SP-104 | Experimental | Drug: SP-104, Drug: Naltrexone immediate release oral capsulesNaltrexone immediate release oral capsule administration with a crossover to SP-104 administration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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-104oral capsule once daily | Drug | Naltrexone immediate release crossover to SP-104, SP-104 crossover to naltrexone immediate release |
| Naltrexone immediate release oral capsulesoral capsule once daily | Drug | Naltrexone immediate release crossover to SP-104, SP-104 crossover to naltrexone immediate release |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: 1 week
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 31 Jan 2022.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 immediate release oral capsules in people with Healthy Volunteers, run by Scilex Pharmaceuticals, Inc. at 2 sites 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 8 inclusion and 15 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 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Incidence of treatment emergent adverse events (time frame: 1 week). 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 31 Jan 2022.