Healthy Adult Male and Female VolunteersPhase 1NCT07269873
Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol
A Phase 1 study testing BICX104 naltrexone implantable pellet, Bupropion 150 mg XL and Naltrexone (depot) in people with Healthy Adult Male and Female Volunteers, run by BioCorRx Pharmaceuticals Inc at 1 site in United States.
Trial 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®). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male and Female Volunteers
- What is being tested?
- BICX104 naltrexone implantable pellet, Bupropion 150 mg XL and Naltrexone (depot)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2026to 5 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Study Site
Miami, Florida, 33106
About this study
Official title: 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
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.
Read more
A total of 30 healthy normal volunteers will be enrolled sequentially in the following cohorts, listed in sequence:
- One BICX104 (1.0 g NTX) implantable pellet (n = 8)
- One BICX104 implantable pellet with 450 mg QD bupropion XL (n = 8)
- Two BICX104 implantable pellets with 450 mg QD bupropion XL (n = 8)
- 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).
- Conditions
- Healthy Adult Male and Female Volunteers
- Being tested
- BICX104 naltrexone implantable pellet, Bupropion 150 mg XL, Naltrexone (depot)
- Keywords
- Safety, Pharmacokinetics (PK), Opioid Use Disorder (OUD), Alcohol Use Disorder (AUD), Methamphetamine Use Disorder (MUD), Healthy Normal Volunteers, Naltrexone
- Medical subject headings
- Opioid-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BICX104 naltrexone implantable pelletDrug
BICX104 naltrexone implantable pellet
Bupropion 150 mg XLDrug
Extended release bupropion
Naltrexone (depot)Drug
Vivitrol naltrexone intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| BICX104 (1 Pellet) | Experimental | 1 naltrexone implantable pellet Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Naltrexone (depot) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration for naltrexone and 6-beta-naltrexol
Measured: From enrollment through Day 196 (28 Weeks)
Tmax
Time to reach maximum plasma concentration for naltrexone and 6-beta-naltrexol
Measured: From enrollment through Day 196 (28 Weeks)
AUC
Area under the concentration-time curve for naltrexone and 6-beta-naltrexol
Measured: From enrollment through Day 196 (28 Weeks)
Tlast
Time to reach the last quantifiable plasma concentration for naltrexone and 6-beta-naltrexol
Measured: 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
Measured: From enrollment through Day 196 (28 Weeks)
Secondary outcomes (1)
Adverse Events (AEs)
Incidence and severity of adverse events
Measured: From enrollment through Day 196 (28 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start16 Mar 2026
- Primary completion5 Dec 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Male and Female VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioCorRx Pharmaceuticals Inc
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269873
- Sponsor's protocol ID
- BICX-25-01b
- Other IDs
- U01DA059994-01
- Status last verified
- May 2026
- First submitted
- 26 Sep 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect the confidentiality of study participants.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07269873
- Acronym / sponsor ID
- BICX-25-01b
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- BioCorRx Pharmaceuticals IncUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- One BICX104 (1.0 g NTX) implantable pellet (n = 8)
- One BICX104 implantable pellet with 450 mg QD bupropion XL (n = 8)
- Two BICX104 implantable pellets with 450 mg QD bupropion XL (n = 8)
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BICX104 (1 Pellet) | Experimental | Drug: BICX104 naltrexone implantable pellet1 naltrexone implantable pellet |
| BICX104 (1 Pellet) + bupropion XL 450 mg QD | Experimental | Drug: BICX104 naltrexone implantable pellet, Drug: Bupropion 150 mg XL1 naltrexone implantable pellet + daily oral bupropion extended release 450 mg QD |
| BICX104 (2 Pellets) + bupropion XL 450 mg QD | Experimental | Drug: BICX104 naltrexone implantable pellet, Drug: Bupropion 150 mg XL2 naltrexone implantable pellets + daily oral bupropion extended release 450 mg QD |
| Vivitrol q 28 days | Active comparator | Drug: Naltrexone (depot)Naltrexone intramuscular injection once every 28 days X 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BICX104 naltrexone implantable pelletBICX104 naltrexone implantable pellet | Drug | BICX104 (1 Pellet), BICX104 (1 Pellet) + bupropion XL 450 mg QD, BICX104 (2 Pellets) + bupropion XL 450 mg QD |
| Bupropion 150 mg XLExtended release bupropion | Drug | BICX104 (1 Pellet) + bupropion XL 450 mg QD, BICX104 (2 Pellets) + bupropion XL 450 mg QD |
| Naltrexone (depot)Vivitrol naltrexone intramuscular injection | Drug | Vivitrol q 28 days |
Primary outcome
Cmax
Time frame: From enrollment through Day 196 (28 Weeks)
Maximum plasma concentration for naltrexone and 6-beta-naltrexol
Tmax
Time frame: From enrollment through Day 196 (28 Weeks)
Time to reach maximum plasma concentration for naltrexone and 6-beta-naltrexol
AUC
Time frame: From enrollment through Day 196 (28 Weeks)
Area under the concentration-time curve for naltrexone and 6-beta-naltrexol
Tlast
Time frame: From enrollment through Day 196 (28 Weeks)
Time to reach the last quantifiable plasma concentration for naltrexone and 6-beta-naltrexol
Tlast ≥ 1 ng/mL
Time frame: From enrollment through Day 196 (28 Weeks)
Time to reach the last quantifiable plasma concentration that is greater than or equal to 1 ng/mL for naltrexone
1 secondary outcome
Adverse Events (AEs)
Time frame: From enrollment through Day 196 (28 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No. IPD will not be shared to protect the confidentiality of study participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BICX104 naltrexone implantable pellet, Bupropion 150 mg XL and Naltrexone (depot) in people with Healthy Adult Male and Female Volunteers, run by BioCorRx Pharmaceuticals Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Recruitment Inquiries, Segal Trials (877-734-2588, studyinquiries@segaltrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: From enrollment through Day 196 (28 Weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.