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

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

Sponsors

Commanditaire principal: BioCorRx Pharmaceuticals, Inc.

Collaborateur: National Institute on Drug Abuse (NIDA)

La source BioCorRx Pharmaceuticals, Inc.
Bref résumé

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.

Situation globale Not yet recruiting
Date de début 2021-07-01
Date d'achèvement 2022-02-01
Date d'achèvement principale 2022-02-01
Phase Phase 1
Type d'étude Interventional
Résultat primaire
Mesure Plage de temps
Pharmacokinetic parameter: Cmax. 140 Days
Pharmacokinetic parameter: Tmax. 140 Days
Pharmacokinetic parameter: Css. 140 Days
Pharmacokinetic parameter: AUC 140 Days
Pharmacokinetic parameter: Tlast ≥ 1ng/ml naltrexone. 140 Days
Pharmacokinetic parameter: Tlast. 140 Days
Résultat secondaire
Mesure Plage de temps
Safety Parameter: AEs 168 Days
Inscription 24
État
Intervention

Type d'intervention: Drug

Nom de l'intervention: BICX104

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

Étiquette du groupe d'armements: BICX104

Type d'intervention: Drug

Nom de l'intervention: Vivitrol

La description: Intramuscular injection containing 380 mg of naltrexone.

Étiquette du groupe d'armements: Vivitrol

Admissibilité

Critères:

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.

Le sexe: All

Âge minimum: 18 Months

Âge maximum: 50 Years

Volontaires en santé: Accepts Healthy Volunteers

Date de vérification

2021-03-01

Partie responsable

Type: Sponsor

A un accès étendu No
Nombre d'armes 2
Groupe d'armes

Étiquette: BICX104

Type: Experimental

La description: 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.

Étiquette: Vivitrol

Type: Active Comparator

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

Données patient No
Informations sur la conception de l'étude

Allocation: Randomized

Modèle d'intervention: Parallel Assignment

Objectif principal: Treatment

Masquage: None (Open Label)

La source: ClinicalTrials.gov

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