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Pharmacokinetic Study of Vivitrol in Healthy Participants

NCT04716881 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-02-23

Study results available
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Summary

This is a Phase I, single-center, single arm, open-label study, to establish the pharmacokinetic (PK) parameters of Vivitrol 380 mg IM injection (IP), a US Food and Drug Administration (FDA) approved medication.

Conditions

  • Opioid-use Disorder

Interventions

DRUG

Naltrexone 380 MG

Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • New York State Psychiatric Institute

    collaborator OTHER

  • Columbia University

    collaborator OTHER

  • Clinilabs, Inc.

    collaborator OTHER

  • Go Medical Industries Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Adam Bisaga, MD · New York State Psychiatric Institute

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2022-04-04
Completion
2022-04-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04716881 on ClinicalTrials.gov