Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

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

Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol (NCT07269873) is a Phase 1 interventional studying Healthy Adult Male and Female Volunteers, sponsored by BioCorRx Pharmaceuticals Inc. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About 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).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Healthy Adult Male and Female Volunteers, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Willing and able to provide willing to sign a consent form 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 Who Should NOT Join This Trial: 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

BICX104 naltrexone implantable pellet

BICX104 naltrexone implantable pellet

DRUG

Bupropion 150 mg XL

Extended release bupropion

DRUG

Naltrexone (depot)

Vivitrol naltrexone intramuscular injection

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Study Site
Miami, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07269873), the sponsor (BioCorRx Pharmaceuticals Inc), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07269873 clinical trial studying?

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 seque… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07269873?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07269873?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07269873. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07269873. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.