NCT04716881

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 9, 2023

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

January 17, 2021

Results QC Date

April 17, 2023

Last Update Submit

February 21, 2024

Conditions

Opioid-use Disorder

Keywords

naltrexoneopioidsOpioid Use Disorder

Outcome Measures

Primary Outcomes (16)

  • Median Cmax of Naltrexone (After 1st Dose)

    Single-dose PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after dosing on Day 0

    1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.

  • Median Tmax of Naltrexone (After 1st Dose)

    Single-dose PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 0

    1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.

  • Median AUC0-inf of Naltrexone (After 1st Dose)

    Single-dose PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0

    1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.

  • Median Ctrough of Naltrexone (After 1st Dose)

    Single-dose PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 0

    1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.

  • Median Cmax of 6β-naltrexol (After First Dose)

    Single-dose PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 0

    1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.

  • Median Tmax of 6β-naltrexol (After 1st Dose)

    Single-dose PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 0

    1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.

  • Median AUC0-inf of 6β-naltrexol (After 1st Dose)

    Single-dose PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 0

    1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.

  • Median Ctrough of 6β-naltrexol (After 1st Dose)

    Single-dose PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 0

    1st dose: Day 0 (predose), 1, 2, 4, 8, 12 hours, 24 hours (Day 1), Days 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, and 28.

  • Median Cmax of Naltrexone (After 6th Dose)

    PK measurement of the maximum observed plasma naltrexone concentration (Cmax) after 6th dose on Day 140

    6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196

  • Median Tmax of Naltrexone (After 6th Dose)

    PK measurement of the time to maximum plasma naltrexone concentration (Tmax) after dosing on Day 140

    6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196

  • Median AUC0-inf of Naltrexone (After 6th Dose)

    PK measurement of the area under the plasma concentration-time curve for naltrexone from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140

    6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196

  • Median Ctrough of Naltrexone (After 6th Dose)

    PK measurement of naltrexone concentration at the end of the dosing interval (Ctrough) after dosing on Day 140

    6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196

  • Median Cmax of 6β-naltrexol (After 6th Dose)

    PK measurement of the maximum observed plasma 6β-naltrexol concentration (Cmax) after dosing on Day 140

    6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196

  • Median Tmax of 6β-naltrexol (After th Dose)

    PK measurement of the time to maximum plasma 6β-naltrexol concentration (Tmax) after dosing on Day 140

    6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196

  • Median AUC0-inf of 6β-naltrexol (After 6th Dose)

    PK measurement of the area under the plasma concentration-time curve for 6β-naltrexol from time 0 extrapolated to infinity (AUC0-inf) after dosing on Day 140

    6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196

  • Median Ctrough of 6β-naltrexol (After 6th Dose)

    PK measurement of 6β-naltrexol concentration at the end of the dosing interval (Ctrough) after dosing on Day 140

    6th dose: Day 140 (1, 2, 4, 8 & 12 hours), 141, 141.5, 141.75, 142, 143, 145, 147, 150, 154, 157, 161, 164, 168, 182 and 196

Secondary Outcomes (7)

  • Adverse Events (AEs)

    Up to Day 196

  • Naltrexone Accumulation Ratio (AR) for Cmax

    196 days after the 6th dose

  • Naltrexone Accumulation Ratio (AR) for Ctrough

    196 days after the 6th dose

  • Naltrexone Accumulation Ratio (AR) for AUC0-inf

    196 days after the 6th dose

  • 6β-naltrexol Accumulation Ratio (AR) for Cmax

    196 days after the 6th dose

  • +2 more secondary outcomes

Study Arms (1)

Vivitrol (naltrexone)

EXPERIMENTAL

Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.

Drug: Naltrexone 380 MG

Interventions

Naltrexone 380 MGDRUG

Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days

Also known as: Vivitrol
Vivitrol (naltrexone)

Eligibility Criteria

Age18 Years - 57 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have completed GM0017 (i.e. been administered OLANI (3.6 gram) and provided two consecutive monthly blood samples of NTX below 0.1 ng/mL)
  • Able and willing to comply with the requirements of the protocol
  • Able and willing to provide written informed consent
  • Willing to undergo an injection of NTX to allow for investigational drug administration in the intramuscular tissue
  • Have an initial weight between 45.3 and 81.6 kilograms (inclusive) or have a BMI inclusive of 18.5 to 30.0.

You may not qualify if:

  • Is currently on active NTX medication.
  • Positive UDS at screening for illicit substances.
  • Has a condition which requires treatment with opioid based medication.
  • Has a known hypersensitivity to NTX.
  • Is prone to skin rashes, irritation or has a skin condition such as recurrent eczema that is likely to impact the injection site area, or as determined by the evaluating physician.
  • Demonstrates any abnormal skin tissue in the proposed injection area.
  • Is pregnant or planning to be. Women need to have negative pregnancy test at screening. Women need to agree to practice an effective method of contraception throughout participation.
  • Participant is breastfeeding or planning to be.
  • Has a current significant neurological (including cognitive and psychiatric disorders),
  • Any clinically important abnormal finding as determined by medical history, physical examination, ECG or clinical laboratory tests.
  • Any additional condition(s) that in the investigator's opinion would prohibit the participant from completing the study or would not be in the best interest of the participant.
  • ALT or AST \>3 times the upper end of the laboratory normal range.
  • Any methadone use 14 days prior to screening, and up to Study Day 0.
  • Any elevated risk for suicide measured using the Columbia Suicide Severity Rating Scale, endorsing any of the items in the past month (C-SSRS, Lifetime)
  • Is participating or intending to participate in any other clinical trial during the duration of this study.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Naltrexonevivitrol

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Director of Operations
Organization
Go Medical Industries, Pty Ltd
ctc@gomedical.com.au
61(8) 9388 1700

Study Officials

  • Adam Bisaga, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2021

First Posted

January 20, 2021

Study Start

January 25, 2021

Primary Completion

April 4, 2022

Study Completion

April 4, 2022

Last Updated

February 23, 2024

Results First Posted

June 9, 2023

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)