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

Phase 1

Completed

• Conditions: Opioid Use Disorder
• Interventions: Drug: RBP-6000; Drug: SUBOXONE Sublingual Film

• Registration Number: NCT02559973
• Lead Sponsor: Indivior Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-25
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RBP-6000 - Light MW	SUBOXONE Sublingual Film	Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a light molecular weight (MW) polymer.
RBP-6000 - Intermediate MW	SUBOXONE Sublingual Film	Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with an intermediate molecular weight (MW) polymer (reference).
RBP-6000 - Heavy MW	RBP-6000	Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a heavy molecular weight (MW) polymer.
RBP-6000 - Heavy MW	SUBOXONE Sublingual Film	Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a heavy molecular weight (MW) polymer.
RBP-6000 - Intermediate MW	RBP-6000	Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with an intermediate molecular weight (MW) polymer (reference).
RBP-6000 - Light MW	RBP-6000	Single subcutaneous injection of RBP-6000 (buprenorphine) 300 mg, formulated with a light molecular weight (MW) polymer.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vince & Associates Clinical Research; 🇺🇸 Overland Park, Kansas, United States