drugset / Trial / NCT04828694
Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections
Phase 1
Completed
24 enrolled
BioCorRx Inc
National Institute on Drug Abuse (NIDA) · collabThe HEAL Initiative (https://heal.nih.gov/) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-06-17
- Primary completion
- 2023-02-22
- Completion
- 2023-03-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 380 mg | Subcutaneous |
| Subject | Naltrexone | Small molecule | 1 g | Subcutaneous |