Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol

Conditions

• Healthy Adult Male and Female Volunteers

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• BICX104 naltrexone implantable pellet — DRUG
  BICX104 naltrexone implantable pellet
• Bupropion 150 mg XL — DRUG
  Extended release bupropion
• Naltrexone (depot) — DRUG
  Vivitrol naltrexone intramuscular injection

Study Details

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).

Key Dates

Start date

Mar 16, 2026

Status verified

May 2026

Primary completion

Dec 5, 2026

Completion

Dec 5, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: BICX104 (1 Pellet)
  1 naltrexone implantable pellet
• Experimental: BICX104 (1 Pellet) + bupropion XL 450 mg QD
  1 naltrexone implantable pellet + daily oral bupropion extended release 450 mg QD
• Experimental: BICX104 (2 Pellets) + bupropion XL 450 mg QD
  2 naltrexone implantable pellets + daily oral bupropion extended release 450 mg QD
• Active Comparator: Vivitrol q 28 days
  Naltrexone intramuscular injection once every 28 days X 3

Primary Outcome Measure

Cmax [ Time Frame: From enrollment through Day 196 (28 Weeks) ]

Central Contacts

• Study Recruitment Inquiries, Segal Trials
  877-734-2588
  [email protected]

Locations (1)

Find similar trials in Miami, FL

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