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

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ClinicalTrials.gov Identifier: NCT02559973
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Indivior Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Drug: RBP-6000 Drug: SUBOXONE Sublingual Film Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : September 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: RBP-6000 - Light MW
Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a light molecular weight (MW) polymer.
 Drug: RBP-6000
RBP-6000 uses buprenorphine in the ATRIGEL Delivery System. The single-syringe is prefilled with RBP-6000 containing 300 mg buprenorphine.
Other Name: 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.
Other Name: buprenorphine HCl and naloxone HCl dihydrate
Experimental: RBP-6000 - Heavy MW
Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a heavy molecular weight (MW) polymer.
 Drug: RBP-6000
RBP-6000 uses buprenorphine in the ATRIGEL Delivery System. The single-syringe is prefilled with RBP-6000 containing 300 mg buprenorphine.
Other Name: 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.
Other Name: buprenorphine HCl and naloxone HCl dihydrate
Active Comparator: RBP-6000 - Intermediate MW
Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with an intermediate molecular weight (MW) polymer (reference).
 Drug: RBP-6000
RBP-6000 uses buprenorphine in the ATRIGEL Delivery System. The single-syringe is prefilled with RBP-6000 containing 300 mg buprenorphine.
Other Name: 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.
Other Name: buprenorphine HCl and naloxone HCl dihydrate


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Maximum Observed Plasma Concentration (Cmax) of Buprenorphine [ Time Frame: Day 1 to Day 57 ]
    Relative bioavailability will also be assessed using Cmax


Secondary Outcome Measures :
  1. Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Norbuprenorphine [ Time Frame: Day 1 to Day 29 ]
  2. Maximum Observed Plasma Concentration (Cmax) of Norbuprenorphine [ Time Frame: Day 1 to Day 57 ]
  3. Participants with Treatment-Emergent Adverse Events [ Time Frame: Day 1 to Day 57 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT02559973


Locations
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United States, Kansas
Vince & Associates Clinical Research
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Indivior Inc.
More Information
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Responsible Party: Indivior Inc.
ClinicalTrials.gov Identifier: NCT02559973    
Other Study ID Numbers: RB-US-13-0006
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Indivior Inc.:
Buprenorphine
opioid use disorder
Additional relevant MeSH terms:
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Disease
Opioid-Related Disorders
Substance-Related Disorders
Pathologic Processes
Narcotic-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Buprenorphine, Naloxone Drug Combination
 Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists