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NCT07269873 · ClinicalTrials.gov registry record · Phase 1
Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol
A Phase 1 study, sponsored by BioCorRx Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT07269873: Recruiting Phase 1 study, sponsored by BioCorRx Pharmaceuticals.
NCT07269873 is a Phase 1 study that is actively recruiting participants, run by BioCorRx Pharmaceuticals. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07269873, a Phase 1 study, is actively recruiting participants, sponsored by BioCorRx Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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. 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
Primary Outcome
Maximum plasma concentration for naltrexone and 6-beta-naltrexol
Interventions
- DRUG Bupropion 150 mg XL
- DRUG BICX104 naltrexone implantable pellet
- DRUG Naltrexone (depot)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-03-16 |
| Est. Completion | 2026-12-05 |
| Phase | Phase 1 |
What NCT07269873 shows while recruiting
NCT07269873 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Bupropion 150 mg XL is the first listed.
NCT07269873 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07269873 about?
NCT07269873 is a clinical study titled "Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol". 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 cur...
What is the current status of trial NCT07269873?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-03-16. Estimated completion is 2026-12-05.
What interventions are being tested in trial NCT07269873?
The interventions under investigation include: Bupropion 150 mg XL (DRUG), BICX104 naltrexone implantable pellet (DRUG), Naltrexone (depot) (DRUG).
Who is sponsoring clinical trial NCT07269873?
This trial is sponsored by BioCorRx Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07269873's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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