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

NCT04828694 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-08-16

No results posted yet for this study

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

  • 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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

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

    collaborator UNKNOWN

  • BioCorRx Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-17
Primary Completion
2023-02-22
Completion
2023-03-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04828694 on ClinicalTrials.gov