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

NCT02559973 | Completed Phase 1

• 1 other identifier: RB-US-13-0006
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

Buprenorphine; opioid use disorder

Outcome Measures

Primary Outcomes (2)

• Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine

  Relative bioavailability will be assessed using AUC0-28days.

  Day 1 to Day 29

• Maximum Observed Plasma Concentration (Cmax) of Buprenorphine

  Relative bioavailability will also be assessed using Cmax

  Day 1 to Day 57

Secondary Outcomes (3)

• Area Under the Concentration-Time Curve from Study Day 1 to Day 29 (AUC0-28days) of Norbuprenorphine

  Day 1 to Day 29

• Maximum Observed Plasma Concentration (Cmax) of Norbuprenorphine

  Day 1 to Day 57

• Participants with Treatment-Emergent Adverse Events

  Day 1 to Day 57

Study Arms (3)

RBP-6000 - Light MW

EXPERIMENTAL

Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a light molecular weight (MW) polymer.

Drug: RBP-6000; Drug: SUBOXONE Sublingual Film

RBP-6000 - Heavy MW

EXPERIMENTAL

Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a heavy molecular weight (MW) polymer.

Drug: RBP-6000; Drug: SUBOXONE Sublingual Film

RBP-6000 - Intermediate MW

ACTIVE COMPARATOR

Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with an intermediate molecular weight (MW) polymer (reference).

Drug: RBP-6000; Drug: SUBOXONE Sublingual Film

Interventions

RBP-6000 DRUG

RBP-6000 uses buprenorphine in the ATRIGEL Delivery System. The single-syringe is prefilled with RBP-6000 containing 300 mg buprenorphine.

Also known as: buprenorphine

RBP-6000 - Heavy MW; RBP-6000 - Intermediate MW; RBP-6000 - Light MW

SUBOXONE Sublingual Film DRUG

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.

Also known as: buprenorphine HCl and naloxone HCl dihydrate

RBP-6000 - Heavy MW; RBP-6000 - Intermediate MW; RBP-6000 - Light MW

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (1)

Vince & Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 25, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 31, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)