Safety and PK Study of BICX104 Naltrexone Implantable Pellet

This study is looking at the safety and how the body handles a new naltrexone implant, called BICX104. Naltrexone is a medicine used to treat addiction. The study compares BICX104, with or without another medicine called bupropion, to an existing naltrexone injection called Vivitrol. Researchers want to see how much of the medicine gets into your body (Cmax, Tmax, AUC) and how long it stays there. You can join if you are a healthy adult male or female between 18 and 65 years old. The study aims to enroll 30 healthy volunteers and will follow participants for about 28 weeks.

Study design
This interventional study plans to enroll 30 healthy adult volunteers. Participants will be divided into 4 groups and receive different treatments.
What's involved
You would be followed for a total of 196 days, which includes a treatment period, a follow-up period, and a post-treatment follow-up period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 196 days, including an 84-day treatment period, an 84-day follow-up period, and a 28-day post-treatment follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07269873

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
BioCorRx Pharmaceuticals Inc
~30 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:BICX104 naltrexone implantable pelletBupropion 150 mg XLNaltrexone (depot)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cmax
Measured over From enrollment through Day 196 (28 Weeks)
+4 more outcomes measured
Healthy Adult Male and Female Volunteers

NCT07269873

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Study Site

    Miami, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study Recruitment Inquiries, Segal Trials
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

  • CmaxFrom enrollment through Day 196 (28 Weeks)

    Maximum plasma concentration for naltrexone and 6-beta-naltrexol

  • TmaxFrom enrollment through Day 196 (28 Weeks)

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

  • AUCFrom enrollment through Day 196 (28 Weeks)

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

  • TlastFrom enrollment through Day 196 (28 Weeks)

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

  • Tlast ≥ 1 ng/mLFrom 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