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

Phase 1

Completed

• Conditions: Opioid-use Disorder
• Interventions: Drug: BICX104; Drug: Vivitrol

• Registration Number: NCT04828694
• Lead Sponsor: BioCorRx Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-02
• Study Start: 2022-06-17
• Primary Completion: 2023-02-22
• Status Verified: 2023-03
• Study Completion: 2023-03-22
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Willing and able to provide informed consent.
2. Female or male subjects aged 18-50 years old.
3. 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.
4. 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.
5. Weight of 100-180 pounds, and a BMI of 18.5 to 30 kg/m2, inclusive.
6. Must agree to comply with all study requirements and be willing to complete entire study.
7. 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).

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Exclusion Criteria

1. Is pregnant, is planning to become pregnant or breastfeed infants during the study.
2. Is currently treated with naltrexone or has had a naltrexone implant in the past 2 years or received Vivitrol treatment in the past year.
3. 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.
4. Presence of opiates, cocaine, methamphetamine or other significant drugs of abuse in the urine (as determined by urine drug test).
5. 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.
6. Manifestation of suicidal ideation, psychotic symptoms (including significant violent behavior), or psychiatric or neurological disorders that would compromise ability to complete the study.
7. Participation in a methadone program currently or within past 3 years, or 3 or more previous medically supervised detoxification treatments in past 3 years.
8. 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.
9. Intolerance and/or hypersensitivity to naltrexone, naloxone, or polylactide-co-polymers such as polylactide-co-glycolide (PLG).
10. Participation in a clinical trial within 30 days of screening.
11. Has a condition which requires or may require treatment with opioid based medication.
12. Is prone to skin rashes, irritation or has a chronic skin condition.
13. Alcohol Use Disorder diagnosis.
14. Has a predisposition to poor response to an implant site reaction, as judged by the study physician.
15. Has a history of keloid formation, connective tissue disease, e.g., scleroderma, or history of recurrent MRSA infections.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BICX104	BICX104	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.
Vivitrol	Vivitrol	Vivitrol intramuscular injection containing 380 mg of naltrexone. Three consecutive doses will be administered once every 28 days for 84 days.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameter: Cmax.	140 Days	Maximum observed mean plasma concentration \[Cmax\] of naltrexone and 6-beta-naltrexol.
Pharmacokinetic parameter: Tmax.	140 Days	Time to mean maximum observed drug concentration (Tmax) of naltrexone and 6-beta-naltrexol.
Pharmacokinetic parameter: Css.	140 Days	Changes in the mean observed steady state plasma concentration \[Css\] of naltrexone and 6-beta-naltrexol.
Pharmacokinetic parameter: Tlast ≥ 1ng/ml naltrexone.	140 Days	Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone greater than or equal to 1ng/ml.
Pharmacokinetic parameter: AUC	140 Days	Area Under the Plasma Concentration Versus Time Curve (AUC) of naltrexone and 6-beta-naltrexol.
Pharmacokinetic parameter: Tlast.	140 Days	Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone and 6-beta-naltrexol.

Secondary Outcome Measures

Name	Time	Method
Safety Parameter: AEs	168 Days	Incidence and severity of adverse events (AEs)

Trial Locations

Locations (1)

Orange County Research Center; 🇺🇸 Tustin, California, United States