Trials / Completed
CompletedNCT04828694
Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections
A Randomized, Open Label, Single Dose Pharmacokinetic and Safety Study of Implantable Long Acting 3-month Naltrexone Subcutaneous Pellets Compared to Naltrexone IM Injection (Vivitrol) in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- BioCorRx Inc · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 1, 6-month, open-label, multi-center study in parallel groups of randomized healthy volunteers to evaluate the pharmacokinetics and safety of BICX104 implantable subcutaneous naltrexone pellets and Vivitrol intramuscular depot naltrexone injection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BICX104 | Erodable implantable pellet containing 1 g naltrexone and 11 mg magnesium stearate. |
| DRUG | Vivitrol | Intramuscular injection containing 380 mg of naltrexone. |
Timeline
- Start date
- 2022-06-17
- Primary completion
- 2023-02-22
- Completion
- 2023-03-22
- First posted
- 2021-04-02
- Last updated
- 2023-08-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04828694. Inclusion in this directory is not an endorsement.