NCT07064564 - BIOPIN 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 1, 2026

Primary Completion Date

May 1, 2027

Study Completion Date

July 1, 2027

Conditions

Opioid Use Disorder

Interventions

DRUG

Naltrexone implant, 14.4 grams

Subcutaneous bioresorbable implant containing 14.4 grams of naltrexone, inserted into the thigh on Day 1 and designed to release drug steadily over 12 months.

DRUG

Naltrexone implant, 9.6 grams

Subcutaneous bioresorbable implant containing 9.6 grams of naltrexone, inserted into the thigh on Day 1 and designed to release drug steadily over 12 months.

DRUG

Extended-release naltrexone injection, 380 mg

Intramuscular injection of 380 mg extended-release naltrexone (Vivitrol), administered every 4 weeks for 12 months as the active comparator.