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

• ClinicalTrials.gov Identifier: NCT04828694
• Recruitment Status: Not yet recruiting
• First Posted: April 2, 2021
• Last Update Posted: April 2, 2021
• Sponsor: BioCorRx Pharmaceuticals, Inc.
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): BioCorRx Pharmaceuticals, Inc.

Study Description

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

Study Design

• 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
• Estimated Study Start Date: July 2021
• Estimated Primary Completion Date: February 2022
• Estimated Study Completion Date: February 2022

Arms and Interventions

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.

Outcome Measures

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)

Eligibility Criteria

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

Criteria

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 30.0 kg/m2, inclusive.
6. Must agree to comply with all study requirements and be willing to complete entire study.
7. Females of childbearing potential willing to practice an effective method of birth control for the duration of participation in the study (double barrier method: condoms, sponge, diaphragm, with spermicidal jellies, or cream).

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. Failed naloxone challenge conducted by a clinician experienced in assessing withdrawal symptoms (the challenge could be repeated up to 2 times, with at least 24 hours between attempts).
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 a poor response to an implant site reaction, as judged by the study physician.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: BioCorRx Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT04828694
• Other Study ID Numbers: BioCorRx-21-01a; UG3DA047925 ( U.S. NIH Grant/Contract )
• First Posted: April 2, 2021
• Last Update Posted: April 2, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Naltrexone; Alcohol Deterrents; Narcotic Antagonists; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents