BICX104 + Bupropion for Opiate Dependence
What You Need to Know Before You Apply
What is the purpose of this trial?
Naltrexone (NTX), an opioid receptor antagonist, has a longstanding history of safe and effective use for the treatment of addictive disorders. NTX is available in several forms, such as daily oral tablets (Revia®) and sustained release monthly injections (Vivitrol®). BioCorRx Pharmaceuticals is currently developing a subcutaneous implantable pellet drug product, BICX104, which contains NTX base anhydrous (997.5 mg) and can be administered via a minor surgical procedure. BICX104 is anticipated to provide plasma concentrations of ≥ 1 ng/mL NTX for 3 months.
Subjects will be enrolled in 4 sequential cohorts and followed for a total of 196 days, comprising an 84-day treatment period, an 84-day follow-up period, and a 28-day post-treatment follow-up period. While therapeutic levels of naltrexone ( ≥ 1 ng/mL plasma concentration) are expected to be maintained throughout the treatment period, intermittent PK sampling will continue through Day 196, at which all subjects are expected to achieve NTX levels below the level of quantitation (BLQ). Safety parameters include assessment of adverse events, vital signs, laboratory parameters, ECG data, and the Columbia Suicide Severity Rating Scale (C-SSRS), and will continue through the final safety visit at Day 196.
A total of 30 healthy normal volunteers will be enrolled sequentially in the following cohorts, listed in sequence:
1. One BICX104 (1.0 g NTX) implantable pellet (n = 8)
2. One BICX104 implantable pellet with 450 mg QD bupropion XL (n = 8)
3. Two BICX104 implantable pellets with 450 mg QD bupropion XL (n = 8)
4. Three consecutive Vivitrol 380 mg injections Q28 days (n = 6) Enrollment will be stratified by biological sex (50% females and 50% males in each cohort)
Subjects will participate in 18 clinic visits over 31 weeks comprising the 3-week screening period, 12-week treatment period, 12-week follow-up period, and 4-week safety follow-up period.
The test products will be BICX104 implantable pellets (dosage: 1 or 2 implants q. 12 weeks), Bupropion XL (dosage: 450 mg QD)
BICX104 will be supplied to the clinical research site in appropriately labeled closed containers; bupropion XL will be supplied in its standard commercial packaging configuration.
The comparator product will be Vivitrol® IM injection (380 mg NTX) (dosage: 1 injection q. 4 weeks) Vivitrol® will be supplied in its standard commercial packaging configuration.
The study assessments will be as follows:
After all screening assessments and the 24-hour Treatment Initiation Visit, safety and PK assessments will occur on Days 3, 5, 7, 14, 21, 28, 42, 56, 70, 84, 98, 112, 126, 140, 154, and 168. Final safety assessments will occur on Day 196. The Treatment Initiation Visit will involve 1 overnight stay and include PK sampling at pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 hours post-dose, in addition to safety assessments.
Safety assessments will include clinical chemistry, hematology, vital signs, physical exam, ECGs, and administration of the Columbia Suicide Severity Rating Scale (C-SSRS).
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-65, with a BMI between 18.5 and 30, who are opioid-free (confirmed by drug tests), able to understand English or Spanish, willing to use birth control if needed, and can commit to all study visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BICX104 implantable pellets with or without bupropion, or Vivitrol injections
Follow-up
Participants are monitored for safety and effectiveness after treatment
Safety Follow-up
Final safety assessments including PK sampling and adverse event monitoring
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares an implantable naltrexone pellet (BICX104) alone or with bupropion pills against monthly Vivitrol injections. Participants are randomly assigned to different groups and monitored over about six months for safety and how the drugs move through the body.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
2 naltrexone implantable pellets + daily oral bupropion extended release 450 mg QD
1 naltrexone implantable pellet + daily oral bupropion extended release 450 mg QD
1 naltrexone implantable pellet
Naltrexone intramuscular injection once every 28 days X 3
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioCorRx Pharmaceuticals Inc
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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