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

NCT04828694 | Completed Phase 1 FDA Drug

• 2 other identifiers: BioCorRx-21-01aUG3DA047925
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetic parameter: Cmax.

  Maximum observed mean plasma concentration \[Cmax\] of naltrexone and 6-beta-naltrexol.

  140 Days

• Pharmacokinetic parameter: Tmax.

  Time to mean maximum observed drug concentration (Tmax) of naltrexone and 6-beta-naltrexol.

  140 Days

• Pharmacokinetic parameter: Css.

  Changes in the mean observed steady state plasma concentration \[Css\] of naltrexone and 6-beta-naltrexol.

  140 Days

• Pharmacokinetic parameter: AUC

  Area Under the Plasma Concentration Versus Time Curve (AUC) of naltrexone and 6-beta-naltrexol.

  140 Days

• Pharmacokinetic parameter: Tlast ≥ 1ng/ml naltrexone.

  Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone greater than or equal to 1ng/ml.

  140 Days

• Pharmacokinetic parameter: Tlast.

  Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone and 6-beta-naltrexol.

  140 Days

Secondary Outcomes (1)

• Safety Parameter: AEs

  168 Days

Study Arms (2)

BICX104

EXPERIMENTAL

BICX104 is an eroding implantable pellet that contains 1 g naltrexone and 11 mg magnesium stearate that will be inserted subcutaneously. It will be administered once for 84 days.

Drug: BICX104

Vivitrol

ACTIVE COMPARATOR

Vivitrol intramuscular injection containing 380 mg of naltrexone. Three consecutive doses will be administered once every 28 days for 84 days.

Drug: Vivitrol

Interventions

BICX104 DRUG

Erodable implantable pellet containing 1 g naltrexone and 11 mg magnesium stearate.

BICX104

Vivitrol DRUG

Intramuscular injection containing 380 mg of naltrexone.

Vivitrol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to provide informed consent.
• Female or male subjects aged 18-50 years old.
• Without current non-remitted DSM-5 (The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) - Substance Use Disorders diagnoses; subjects with a sustained remission diagnosis are not excluded.
• In good health, as determined by the study physician, based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests within normal ranges, to permit treatment.
• Weight of 100-180 pounds, and a BMI of 18.5 to 30 kg/m2, inclusive.
• Must agree to comply with all study requirements and be willing to complete entire study.
• Females of childbearing potential and males willing to practice an effective method(s) of birth control for the duration of participation in the study (\<1% failure rate per year).

You may not qualify if:

• Is pregnant, is planning to become pregnant or breastfeed infants during the study.
• Is currently treated with naltrexone or has had a naltrexone implant in the past 2 years or received Vivitrol treatment in the past year.
• Clinically significant medical/psychological condition or abnormality at screening (i.e., physical examination, electrocardiogram \[ECG\], hematology or blood chemistry evaluation, or urinalysis findings), including any diagnosis of Hepatitis B, Hepatitis C or HIV infection.
• Presence of opiates, cocaine, methamphetamine or other significant drugs of abuse in the urine (as determined by urine drug test).
• Any active hepatitis or hepatic failure or dysfunction evidenced by the following: aspartate transaminase (AST) or alanine transaminase (ALT) higher than 1.5 times the upper limit of normal (1.5xULN), hyperbilirubinemia (bilirubin \>10% above ULN), creatine phosphokinase (CPK) higher than 2.5xULN, prolonged prothrombin time (international normalized ratio ≥1.7), ascites, or esophageal variceal disease.
• Manifestation of suicidal ideation, psychotic symptoms (including significant violent behavior), or psychiatric or neurological disorders that would compromise ability to complete the study.
• Participation in a methadone program currently or within past 3 years, or 3 or more previous medically supervised detoxification treatments in past 3 years.
• If a healthy volunteer fails one naloxone challenge, the subject will not be suitable for the study. The only exceptions will be made when a 'false positive' test result is received for the first test.
• Intolerance and/or hypersensitivity to naltrexone, naloxone, or polylactide-co-polymers such as polylactide-co-glycolide (PLG).
• Participation in a clinical trial within 30 days of screening.
• Has a condition which requires or may require treatment with opioid based medication.
• Is prone to skin rashes, irritation or has a chronic skin condition.
• Alcohol Use Disorder diagnosis.
• Has a predisposition to poor response to an implant site reaction, as judged by the study physician.
• Has a history of keloid formation, connective tissue disease, e.g., scleroderma, or history of recurrent MRSA infections.

Sponsors & Collaborators

• BioCorRx Inc: lead
• National Institute on Drug Abuse (NIDA): collaborator
• The HEAL Initiative (https://heal.nih.gov/): collaborator

Study Sites (1)

Orange County Research Center

Tustin, California, 92780, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

vivitrol

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 2, 2021
• Study Start: June 17, 2022
• Primary Completion: February 22, 2023
• Study Completion: March 22, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)