The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers

NCT03810495 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: GM0017UG3DA047720240358
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated in an open label manner. No randomization will occur. It is hypothesized that the OLANI will provide sustained therapeutic doses of naltrexone (NTX) for periods up to 6 months via a single subcutaneous application of 2 OLANIs.

Conditions

Opioid Use Disorder

Keywords

naltrexone; opioids; opioid use disorder; OLANI implant

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants That Maintain MEC

  Percentage of participants who maintain naltrexone (NTX) blood levels of ≥1.33 ng/mL for ≥180 days

  up to 540 days or until NTX blood levels become undetectable

Secondary Outcomes (8)

• Median Cmax of Naltrexone

  pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days

• Tmax of Naltrexone

  pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days

• AUC of Naltrexone

  pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days

• Median Cmax of 6β-naltrexol

  pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days

• Median Tmax of 6β-naltrexol

  pre-dose, at 3, 6, and 12 hours (± 60 minutes) after dosing; 24 and 48 hours (± 2 hours) after dosing; day 4 (± 1 day), day 8 (± 2 days); days 14, 21, 28, 35, 42, 49 and 56 (± 3 days); then every 30 days (± 10 days) up to 540 days

Study Arms (1)

OLANI (naltrexone implant)

EXPERIMENTAL

2 OLANI containing 60% naltrexone (1.8 g total) administered one time subcutaneously

Drug: naltrexone implant

Interventions

naltrexone implant DRUG

1.8 g implant containing 60% naltrexone

Also known as: OLANI, O'Neil Long Acting Naltrexone Implant

OLANI (naltrexone implant)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women between the ages of 18 and 55 years old (inclusive)
• Able and willing to comply with the requirements of the protocol
• Able and willing to provide written informed consent
• Willing to undergo a minor surgical procedure under local anesthetic to allow for investigational drug administration in the subcutaneous tissue
• BMI inclusive of 18.5 to 30.0
• Have an initial weight between 45.3 and 81.6 kilograms (inclusive)

You may not qualify if:

• Positive urine drug screen (UDS) at screening for illicit substances.
• Is currently on naltrexone medication.
• Has had a naltrexone implant in the past 24 months.
• Has received treatment with an extended naltrexone product (e.g. Vivitrol) in the past 12 months.
• Has a condition which requires treatment with opioid based medication.
• Has a known hypersensitivity to naltrexone.
• Has a known hypersensitivity to poly-lactic based materials e.g. biodegradable sutures, surgical implants or previous biodegradable implants.
• Has a known hypersensitivity to local anesthesia.
• Is prone to skin rashes, irritation or has a skin condition such as recurrent eczema that is likely to impact the implant site area, or as determined by the evaluating physician.
• Demonstrates any abnormal skin tissue in the proposed implantation area.
• Is pregnant or planning to be. Women need to have negative blood pregnancy test at screening. Women need to agree to practice dual contraceptives.
• Participant is breastfeeding or planning to be.
• Has a current significant neurological (including cognitive and psychiatric disorders), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological or metabolic disease unless currently controlled and stable with protocol-allowed medication 30 days prior to proposed investigational product administration.
• 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.

Sponsors & Collaborators

• Go Medical Industries Pty Ltd: lead
• National Institute on Drug Abuse (NIDA): collaborator
• New York State Psychiatric Institute: collaborator
• Columbia University: collaborator
• Clinilabs, Inc.: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

This is a pilot study with a small sample size.

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: OTHER
• 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, 2019
• First Posted: January 18, 2019
• Study Start: April 11, 2019
• Primary Completion: March 18, 2021
• Study Completion: March 22, 2021
• Last Updated: November 12, 2024
• Results First Posted: August 1, 2022

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)