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Pharmacokinetic Study of Vivitrol in Healthy Participants

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ClinicalTrials.gov Identifier: NCT04716881
Recruitment Status : Enrolling by invitation
First Posted : January 20, 2021
Last Update Posted : September 21, 2021
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Columbia University
Clinilabs, Inc.
Information provided by (Responsible Party):
Go Medical Industries Pty Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Drug: Naltrexone 380 MG Phase 1

Detailed Description:

This is a Phase I, single-center, single arm, open-label study, to establish the PK parameters of Vivitrol 380 mg IM injection (IP), a US FDA approved medication. Participants will be healthy volunteers with no significant medical or mental health disorders, who have completed participation in clinical trial GM 0017 (i.e. have received the OLANI treatment and have subsequently provided two consecutive plasma levels of naltrexone (NTX) <0.1ng/mL).

This study will examine the PK profile of Vivitrol IM 380 mg over 6 doses for a treatment period of 196 days. Intense sampling will occur after the 1st and 6th dose of Vivitrol. Participants will be without a DSM 5 - Substance Related Disorders classification. Participants will be required to undergo a Naloxone Challenge Test (NCT) to confirm opiate naivety before administration of the IP. No randomization will occur.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pharmacokinetic Study of Vivitrol in Healthy Participants
Actual Study Start Date : January 18, 2021
Estimated Primary Completion Date : May 15, 2022
Estimated Study Completion Date : August 15, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vivitrol (naltrexone)
Intramuscular injection of Vivitrol (naltrexone), 380 mg. Six doses given 28 days apart.
 Drug: Naltrexone 380 MG
Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
Other Name: Vivitrol


Outcome Measures
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Primary Outcome Measures :
  1. Mean Cmax of naltrexone [ Time Frame: 1st dose: Day 0 (predose, +1, 2, 4, 8, 12 & 24 hours), 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, 28 days. 2nd-5th dose: 56, 84, 112, 140 days. Then repeat intensive PK for the 6th dose. ]
    Single-dose PK measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1

  2. Mean Tmax of naltrexone [ Time Frame: 1st dose: Day 0 (predose, +1, 2, 4, 8, 12 & 24 hours), 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, 28 days. 2nd-5th dose: 56, 84, 112, 140 days. Then repeat intensive PK for the 6th dose. ]
    Single-dose PK measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1

  3. AUC of naltrexone [ Time Frame: 1st dose: Day 0 (predose, +1, 2, 4, 8, 12 & 24 hours), 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, 28 days. 2nd-5th dose: 56, 84, 112, 140 days. Then repeat intensive PK for the 6th dose. ]
    Single-dose PK measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1

  4. Ctrough of naltrexone [ Time Frame: 1st dose: Day 0 (predose, +1, 2, 4, 8, 12 & 24 hours), 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, 28, 54, 84, 112, 140, and 168 ]
    Single-dose PK measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1

  5. Cmax of 6β-naltrexol [ Time Frame: 1st dose: Day 0 (predose, +1, 2, 4, 8, 12 & 24 hours), 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, 28 days. 2nd-5th dose: 56, 84, 112, 140 days. Then repeat intensive PK for the 6th dose. ]
    Single-dose PK measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1

  6. Tmax of 6β-naltrexol [ Time Frame: 1st dose: Day 0 (predose, +1, 2, 4, 8, 12 & 24 hours), 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, 28 days. 2nd-5th dose: 56, 84, 112, 140 days. Then repeat intensive PK for the 6th dose. ]
    Single-dose PK measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1

  7. AUC of 6β-naltrexol [ Time Frame: 1st dose: Day 0 (predose, +1, 2, 4, 8, 12 & 24 hours), 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, 28 days. 2nd-5th dose: 56, 84, 112, 140 days. Then repeat intensive PK for the 6th dose. ]
    Single-dose PK measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1

  8. Ctrough of 6β-naltrexol [ Time Frame: 1st dose: Day 0 (predose, +1, 2, 4, 8, 12 & 24 hours), 1.5, 1.75, 2, 3, 5, 7, 10, 14, 17, 21, 24, 28, 54, 84, 112, 140, and 168 ]
    Single-dose PK measurement of the plasma naltrexone concentration (Cmax) after dosing on Day 1


Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to Day 196 ]
    Incidence and Severity of AEs


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 56 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)
  • Men or women between ≥18 and <57 years old Without DSM 5 - Substance Related Disorders classification; in sustained remission is not exclusionary
  • 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.

Exclusion Criteria:

  • 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.
  • Current DSM 5 diagnosis of schizophrenia, bipolar, anxiety, or depressive disorder, confirmed by MINI assessment, or currently treated with medications for anxiety or depression. Past history (in remission DSM 5 classification) of anxiety or depression is not exclusionary.
  • 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.
  • Is allergic to any of the ingredients in Vivitrol or the diluent used to mix Vivitrol (i.e. carboxymethylcellulose sodium, polysorbate 20, sodium chloride, sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716881


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Go Medical Industries Pty Ltd
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Columbia University
Clinilabs, Inc.
Investigators
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Principal Investigator: Adam Bisaga, MD New York State Psychiatric Institute
More Information
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Responsible Party: Go Medical Industries Pty Ltd
ClinicalTrials.gov Identifier: NCT04716881    
Other Study ID Numbers: GM0019
UG3DA047720 ( U.S. NIH Grant/Contract )
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Go Medical Industries Pty Ltd:
naltrexone
opioids
Opioid Use Disorder
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
 Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents