Status:
COMPLETED
Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections
Lead Sponsor:
BioCorRx Inc
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
The HEAL Initiative (https://heal.nih.gov/)
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 naltrexon...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
June 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04828694
Start Date
June 17 2022
End Date
March 22 2023
Last Update
August 16 2023
Active Locations (1)
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1
Orange County Research Center
Tustin, California, United States, 92780