Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 17, 2022

Primary Completion Date

February 22, 2023

Study Completion Date

March 22, 2023

Conditions
Opioid-use Disorder
Interventions
DRUG

BICX104

Erodable implantable pellet containing 1 g naltrexone and 11 mg magnesium stearate.

DRUG

Vivitrol

Intramuscular injection containing 380 mg of naltrexone.

Trial Locations (1)

92780

Orange County Research Center, Tustin

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

collaborator

The HEAL Initiative (https://heal.nih.gov/)

UNKNOWN

lead

BioCorRx Inc

INDUSTRY