Safety and drug levels of a 3‑month naltrexone implant (BICX104) with or without bupropion versus monthly Vivitrol injections

A Sequential Dose Cohort Pharmacokinetic and Safety Study of Implantable Long-Acting Naltrexone Subcutaneous Pellets With or Without Bupropion Compared to Naltrexone IM Injection (Vivitrol®) in Healthy Normal Volunteers

This will test whether a three‑month naltrexone implant (BICX104), given alone or with extended‑release bupropion, is safe and keeps steady drug levels compared with monthly Vivitrol injections in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: BioCorRx Pharmaceuticals Inc (Academic / other)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT07269873 on ClinicalTrials.gov

What this trial studies

This Phase 1 study enrolls healthy adults aged 18–65 to measure safety and pharmacokinetics of a subcutaneous naltrexone implant (BICX104) containing 997.5 mg naltrexone base anhydrous, with some cohorts also receiving bupropion 150 mg XL, compared to injectable naltrexone (Vivitrol). Subjects are enrolled in four sequential cohorts and followed for a total of 196 days, including an 84‑day treatment period, an 84‑day follow‑up, and a 28‑day post‑treatment period, with intermittent PK sampling through Day 196. The implant is placed via a minor surgical procedure and is anticipated to provide plasma naltrexone concentrations ≥1 ng/mL for about three months. The primary endpoints focus on safety and drug concentration profiles over the follow‑up period.

Who should consider this trial

Good fit: Healthy adults 18–65 who are opioid‑free, meet BMI and health screening criteria (BMI 18.5–30), agree to the implant procedure and study visits, and can complete the full study are eligible.

Not a fit: People actively using opioids, with significant psychiatric illness or suicidal risk, who are pregnant or breastfeeding, or who do not meet the health/BMI criteria are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, the implant could provide three months of naltrexone coverage without monthly injections, improving convenience and adherence for people needing naltrexone.

How similar studies have performed: Long‑acting injectable naltrexone (Vivitrol) has established effectiveness for opioid and alcohol disorders, while subcutaneous naltrexone implants are a newer formulation with limited prior human data.

Eligibility criteria

Inclusion Criteria:

1. Willing and able to provide informed consent and to read and understand study documents in English or Spanish
2. Female or male subjects aged 18-65 years old
3. In good health, as determined by the study physician, based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests within normal ranges, to permit treatment.
4. Meet subjective and objective measures of being opioid-free prior to study treatment initiation, including negative urine drug screen results at screening and enrollment.
5. BMI of 18.5 to 30.0 kg/m2, inclusive.
6. Must agree to comply with all study requirements and be willing to complete entire study.
7. Persons of childbearing potential agree to use acceptable birth control methods and have periodic urine pregnancy testing done during participation in the study

Exclusion Criteria:

1. Have a history of any psychiatric disorder OR suicidal ideation, behavior, or risk of self-harm as evidenced by endorsement of items 2, 3, 4, or 5 on the C-SSRS
2. Have a history of angle-closure glaucoma
3. Have a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization); current anorexia nervosa or bulimia; or any other conditions that increase seizure risk in the opinion of the study medical clinician
4. Have evidence of second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc interval (\> 450 in males or \> 470 in females), or any other finding on the screening ECG that, in the opinion of the study medical clinician, would preclude safe participation in the study
5. Have Stage 2 hypertension as determined by the study medical clinician (e.g., greater than or equal to 160/100 in 2 out of 3 readings during screening)
6. Have any elevated bilirubin test value, or AST, ALT or alkaline phosphatase \> 1.5 times the upper limit of normal, per laboratory criteria
7. Have a platelet count \<100 x 103/μL; known coagulopathy, or need for anticoagulant therapy during the study
8. Have a known allergy or sensitivity to bupropion, naltrexone, or magnesium stearate, or any topical antiseptics or local anesthetics to be used in the implant procedure.
9. Have taken an investigational drug in another study within 30 days of study consent
10. Have a history of any substance abuse disorder, have been prescribed and taken naltrexone or bupropion within 30 days of study consent, or have been administered Vivitrol® within 60 days of study consent
11. Be receiving ongoing treatment with antidepressants, xanthines (i.e., theophylline and aminophylline), systemic corticosteroids, nelfinavir, efavirenz, chlorpromazine, MAOIs, central nervous system stimulants (e.g., Adderall, Ritalin, etc.), or any medication that, in the judgment of the study medical clinician, could interact adversely with study medications
12. Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study as determined by the study medical clinician
13. Require treatment with opioid-containing medications (e.g., opioid analgesics) during the study period
14. Have a surgery planned or scheduled during the study period
15. Are currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that could prevent participation in the study or in any study activities
16. Is prone to skin rashes, keloid scars, or irritation, or has a chronic skin condition or any other condition which might predispose them to adverse reactions to the implant procedure.

Where this trial is running

Miami, Florida

• Study Site — Miami, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Study Recruitment Inquiries, Segal Trials

Conditions Healthy Adult Male and Female Volunteers; Safety; Pharmacokinetics; Opioid Use Disorder; Alcohol Use Disorder; Methamphetamine Use Disorder; Healthy Normal Volunteers; Naltrexone