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

Sponsoren

Hauptsponsor: BioCorRx Pharmaceuticals, Inc.

Mitarbeiter: National Institute on Drug Abuse (NIDA)

Quelle BioCorRx Pharmaceuticals, Inc.
Kurze Zusammenfassung

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.

Gesamtstatus Not yet recruiting
Anfangsdatum 2021-07-01
Fertigstellungstermin 2022-02-01
Primäres Abschlussdatum 2022-02-01
Phase Phase 1
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
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
Sekundäres Ergebnis
Messen Zeitfenster
Safety Parameter: AEs 168 Days
Einschreibung 24
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: BICX104

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

Armgruppenetikett: BICX104

Interventionsart: Drug

Interventionsname: Vivitrol

Beschreibung: Intramuscular injection containing 380 mg of naltrexone.

Armgruppenetikett: Vivitrol

Teilnahmeberechtigung

Kriterien:

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.

Geschlecht: All

Mindestalter: 18 Months

Maximales Alter: 50 Years

Gesunde Freiwillige: Accepts Healthy Volunteers

Überprüfungsdatum

2021-03-01

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Anzahl der Waffen 2
Armgruppe

Etikette: BICX104

Art: Experimental

Beschreibung: 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.

Etikette: Vivitrol

Art: Active Comparator

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

Patientendaten No
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov

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