Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder

Overview

This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential (Inpatient) and Non-Residential (Outpatient) Period.

Full Title of Study: “A Single-Center, Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine (RBP-6000) Using Poly (DL-lactide-co-glycolide) Polymer of Two Different Molecular Weights (Low and High Molecular Weights as Test Treatments) in Comparison to Intermediate Molecular Weight (Reference Treatment) in Treatment-Seeking Subjects With Opioid Use Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2016

Interventions

  • Drug: RBP-6000
    • RBP-6000 uses buprenorphine in the ATRIGEL Delivery System. The single-syringe is prefilled with RBP-6000 containing 300 mg buprenorphine.
  • Drug: SUBOXONE Sublingual Film
    • Subjects will be dose-stabilized on SUBOXONE sublingual film prior to administration of RBP-6000. SUBOXONE sublingual film will be administered beginning after the subject is experiencing signs and symptoms of withdrawal on Day -8 and continue until Day -1.

Arms, Groups and Cohorts

  • Experimental: RBP-6000 – Light MW
    • Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a light molecular weight (MW) polymer.
  • Experimental: RBP-6000 – Heavy MW
    • Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a heavy molecular weight (MW) polymer.
  • Active Comparator: RBP-6000 – Intermediate MW
    • Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with an intermediate molecular weight (MW) polymer (reference).

Clinical Trial Outcome Measures

Primary Measures

  • Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
    • Time Frame: Day 1 to Day 29
    • Relative bioavailability will be assessed using AUC0-28days.
  • Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
    • Time Frame: Day 1 to Day 57
    • Relative bioavailability will also be assessed using Cmax

Secondary Measures

  • Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Norbuprenorphine
    • Time Frame: Day 1 to Day 29
  • Maximum Observed Plasma Concentration (Cmax) of Norbuprenorphine
    • Time Frame: Day 1 to Day 57
  • Participants with Treatment-Emergent Adverse Events
    • Time Frame: Day 1 to Day 57

Participating in This Clinical Trial

Inclusion Criteria

  • Currently meets DSM-5 criteria for moderate or severe opioid use disorder (OUD)
  • Is seeking treatment for OUD
  • Body mass index: ≥ 18.0 to ≤ 35.0 kg/m^2
  • Females: Female individuals of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from Screening through at least 6 months after the last dose of Investigational Medicinal Product (IMP).
  • Males: Male individuals with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the informed consent form through at least 6 months after the last dose of IMP. Male individuals must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP.
  • Have a normal electrocardiogram (ECG) or ECG with no clinically significant findings in the opinion of the Investigator or medically qualified sub-investigator at Screening and through pre-dose on Day 1.
  • Agree not to take any buprenorphine-containing products, other than those administered for the current study, throughout the duration of the study.
  • Willing to adhere to study procedures and provide written informed consent prior to start of any study procedures.

Exclusion Criteria

  • Current diagnosis, other than OUD, requiring chronic opioid treatment.
  • Pregnant or lactating females.
  • Have an ECG demonstrating a corrected QT interval using Fridericia's calculation (QTcF) > 450 msec in males and QTcF > 470 msec in females upon admission to the residential facility or prior to administration of RBP-6000.
  • Currently meet the criteria for diagnosis of moderate or severe substance use disorder, by DSM-5 criteria, for any substances other than opioids, and/or tobacco.
  • Had a significant traumatic injury, major surgery, or open biopsy within the 4 weeks prior to signing the informed consent form.
  • Used buprenorphine-containing products within the 14 days prior to signing the informed consent form.
  • Have a history of suicidal ideation within the 30 days prior to signing the informed consent form or prior to study drug administration
  • Have a history or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine, naloxone, methadone, or the ATRIGEL Delivery System.
  • Individuals who have a positive urine drug screen (UDS) prior to admission to the residential facility for barbiturates, benzodiazepines, buprenorphine, or methadone.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indivior Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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