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Study to Evaluate the Safety of SP-104

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04958876
Recruitment Status : Completed
First Posted : July 12, 2021
Last Update Posted : January 31, 2022
Sponsor:
Information provided by (Responsible Party):
Scilex Pharmaceuticals, Inc.

Brief Summary:
Evaluate the safety and tolerability of 3-day repeat-dose of SP-104 compared to naltrexone hydrochloride immediate release.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: SP-104 Drug: Naltrexone immediate release oral capsules Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 4, 2021
Actual Primary Completion Date : December 20, 2021
Actual Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine


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
Drug: SP-104
oral capsule once daily

Drug: Naltrexone immediate release oral capsules
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
Drug: SP-104
oral capsule once daily

Drug: Naltrexone immediate release oral capsules
oral capsule once daily




Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events [ Time Frame: 1 week ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04958876


Locations
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New Zealand
Auckland Clinical Studies (NZCR)
Auckland, New Zealand, 1010
Christchurch Clinical Studies Trust (NZCR)
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Scilex Pharmaceuticals, Inc.
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Responsible Party: Scilex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04958876    
Other Study ID Numbers: SP-104-02
First Posted: July 12, 2021    Key Record Dates
Last Update Posted: January 31, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents