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

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ClinicalTrials.gov Identifier: NCT04828694
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : July 20, 2022
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Drug: BICX104 Drug: Vivitrol Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Single Dose Pharmacokinetic and Safety Study of Implantable Long Acting 3-month Naltrexone Subcutaneous Pellets Compared to Naltrexone IM Injection (Vivitrol) in Healthy Volunteers
Actual Study Start Date : June 17, 2022
Estimated Primary Completion Date : December 5, 2022
Estimated Study Completion Date : March 27, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Drug: BICX104
Erodable implantable pellet containing 1 g naltrexone and 11 mg magnesium stearate.

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

Primary Outcome Measures :
  1. Pharmacokinetic parameter: Cmax. [ Time Frame: 140 Days ]
    Maximum observed mean plasma concentration [Cmax] of naltrexone and 6-beta-naltrexol.

  2. Pharmacokinetic parameter: Tmax. [ Time Frame: 140 Days ]
    Time to mean maximum observed drug concentration (Tmax) of naltrexone and 6-beta-naltrexol.

  3. Pharmacokinetic parameter: Css. [ Time Frame: 140 Days ]
    Changes in the mean observed steady state plasma concentration [Css] of naltrexone and 6-beta-naltrexol.

  4. Pharmacokinetic parameter: AUC [ Time Frame: 140 Days ]
    Area Under the Plasma Concentration Versus Time Curve (AUC) of naltrexone and 6-beta-naltrexol.

  5. Pharmacokinetic parameter: Tlast ≥ 1ng/ml naltrexone. [ Time Frame: 140 Days ]
    Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone greater than or equal to 1ng/ml.

  6. Pharmacokinetic parameter: Tlast. [ Time Frame: 140 Days ]
    Time of Last Quantifiable Plasma Concentration (Tlast) of naltrexone and 6-beta-naltrexol.

Secondary Outcome Measures :
  1. Safety Parameter: AEs [ Time Frame: 168 Days ]
    Incidence and severity of adverse events (AEs)

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

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.

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): NCT04828694

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Contact: Brady Granier 714-462-4884 brady@biocorrx.com
Contact: Joel Neutel, M.D. 714-550-9990 NeutelMD@OCResearchCenter.com

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United States, California
Orange County Research Center Recruiting
Tustin, California, United States, 92780
Contact: Joel Neutel, MD    714-550-9990    NeutelMD@OCResearchCenter.com   
Sponsors and Collaborators
BioCorRx Inc
National Institute on Drug Abuse (NIDA)
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Responsible Party: BioCorRx Inc
ClinicalTrials.gov Identifier: NCT04828694    
Other Study ID Numbers: BioCorRx-21-01a
UG3DA047925 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
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
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents