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

NCT07269873 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: BICX-25-01bU01DA059994-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.One BICX104 (1.0 g NTX) implantable pellet (n = 8)
2. 2.One BICX104 implantable pellet with 450 mg QD bupropion XL (n = 8)
3. 3.Two BICX104 implantable pellets with 450 mg QD bupropion XL (n = 8)
4. 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)

Conditions

Healthy Adult Male and Female Volunteers

Keywords

Safety; Pharmacokinetics (PK); Opioid Use Disorder (OUD); Alcohol Use Disorder (AUD); Methamphetamine Use Disorder (MUD); Healthy Normal Volunteers; Naltrexone

Outcome Measures

Primary Outcomes (5)

• Cmax

  Maximum plasma concentration for naltrexone and 6-beta-naltrexol

  From enrollment through Day 196 (28 Weeks)

• Tmax

  Time to reach maximum plasma concentration for naltrexone and 6-beta-naltrexol

  From enrollment through Day 196 (28 Weeks)

• AUC

  Area under the concentration-time curve for naltrexone and 6-beta-naltrexol

  From enrollment through Day 196 (28 Weeks)

• Tlast

  Time to reach the last quantifiable plasma concentration for naltrexone and 6-beta-naltrexol

  From enrollment through Day 196 (28 Weeks)

• Tlast ≥ 1 ng/mL

  Time to reach the last quantifiable plasma concentration that is greater than or equal to 1 ng/mL for naltrexone

  From enrollment through Day 196 (28 Weeks)

Secondary Outcomes (1)

• Adverse Events (AEs)

  From enrollment through Day 196 (28 weeks)

Study Arms (4)

BICX104 (1 Pellet)

EXPERIMENTAL

1 naltrexone implantable pellet

Drug: BICX104 naltrexone implantable pellet

BICX104 (1 Pellet) + bupropion XL 450 mg QD

EXPERIMENTAL

1 naltrexone implantable pellet + daily oral bupropion extended release 450 mg QD

Drug: BICX104 naltrexone implantable pellet; Drug: Bupropion 150 mg XL

BICX104 (2 Pellets) + bupropion XL 450 mg QD

EXPERIMENTAL

2 naltrexone implantable pellets + daily oral bupropion extended release 450 mg QD

Drug: BICX104 naltrexone implantable pellet; Drug: Bupropion 150 mg XL

Vivitrol q 28 days

ACTIVE COMPARATOR

Naltrexone intramuscular injection once every 28 days X 3

Drug: Naltrexone (depot)

Interventions

BICX104 naltrexone implantable pellet DRUG

BICX104 naltrexone implantable pellet

BICX104 (1 Pellet); BICX104 (1 Pellet) + bupropion XL 450 mg QD; BICX104 (2 Pellets) + bupropion XL 450 mg QD

Bupropion 150 mg XL DRUG

Extended release bupropion

BICX104 (1 Pellet) + bupropion XL 450 mg QD; BICX104 (2 Pellets) + bupropion XL 450 mg QD

Naltrexone (depot) DRUG

Vivitrol naltrexone intramuscular injection

Vivitrol q 28 days

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent and to read and understand study documents in English or Spanish
• Female or male subjects aged 18-65 years old
• 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.
• Meet subjective and objective measures of being opioid-free prior to study treatment initiation, including negative urine drug screen results at screening and enrollment.
• BMI of 18.5 to 30.0 kg/m2, inclusive.
• Must agree to comply with all study requirements and be willing to complete entire study.
• Persons of childbearing potential agree to use acceptable birth control methods and have periodic urine pregnancy testing done during participation in the study

You may not qualify if:

• 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
• Have a history of angle-closure glaucoma
• 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
• 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
• 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)
• Have any elevated bilirubin test value, or AST, ALT or alkaline phosphatase \> 1.5 times the upper limit of normal, per laboratory criteria
• Have a platelet count \<100 x 103/μL; known coagulopathy, or need for anticoagulant therapy during the study
• 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.
• Have taken an investigational drug in another study within 30 days of study consent
• 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
• 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
• 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
• Require treatment with opioid-containing medications (e.g., opioid analgesics) during the study period
• Have a surgery planned or scheduled during the study period
• 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

Sponsors & Collaborators

• BioCorRx Pharmaceuticals Inc: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Opioid-Related Disorders; Alcoholism

Interventions

Bupropion; Naltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Study Recruitment Inquiries, Segal Trials

CONTACT

877-734-2588; studyinquiries@segaltrials.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: December 8, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 5, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share