Single-dose, Study of RBP-6000 in Opioid Dependent Individuals

NCT02765867 | Completed Phase 1

• 1 other identifier: RB-US-10-0011
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an injection of RBP-6000.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• To assess the incidence of treatment emergent adverse events (safety and tolerability) of a single SC injection of RBP-6000 in subjects with opioid dependence.

  The frequency of all adverse events (AE) and serious adverse events (SAE) deemed to be related to treatment.

  Day 1 to Day 85

Secondary Outcomes (3)

• Maximum plasma concentration (Cmax) for buprenorphine and norbuprenorphine

  Day 1 through Day 85

• Time to occurrence of Cmax (Tmax) for buprenorphine and norbuprenorphine

  Day 1 through Day 85

• Area under the plasma concentration versus time curve (AUC) for buprenorphine and norbuprenorphine

  Day 1 through Day 85

Study Arms (1)

RBP-6000

EXPERIMENTAL

A single dose of RBP-6000 will be administered on Study Day 1

Drug: RBP-6000

Interventions

RBP-6000 DRUG

A single injection of RBP-6000 containing a low dose of buprenorphine in the Atrigel delivery system

RBP-6000

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• If female, must be surgically sterile or two-years post-menopausal and have a negative pregnancy test. Subjects should take reasonable precautions during the study to avoid pregnancy by agreeing to remain abstinent or to practice double-barrier forms of birth control from study screening through the last dose of study medication.
• Meet Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for opioid dependence and who are seeking opioid-dependence treatment with methadone.
• Willing to cooperate with study procedures and provide written informed consent prior to start of any study procedures.
• Agree not to take any buprenorphine product (other than RBP-6000) throughout their participation in the study.
• Body mass index of ≥ 18 to ≤ 33 kg/m2.
• Total bilirubin \< 2.5 mg/dL (51 μmol/L), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3 × the upper limit of normal (ULN), serum creatinine \< 2 x ULN, or international normalized ratio (INR) ≤ 2.0.
• Normal or no clinically significant ECG findings at screening

You may not qualify if:

• Require ongoing opioid therapy for pain or other chronic medical conditions.
• Additionally, individuals who answer "yes" to both of the following questions will be excluded from participation: A) Throughout our lives, most of us have had pain from time to time (such as minor headaches, sprains, and toothaches). Have you had pain other than those kinds of pain today? B) If yes, has the pain persisted for three months or more?
• Currently dependent by DSM-IV-TR criteria on any substance other than opioids, caffeine, or nicotine.
• Positive urine screen at intake for barbiturates, benzodiazepines, buprenorphine, or methadone.
• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the study physician, would jeopardize the safety of the subject.
• Clinically significant abnormal finding on physical exam or in medical history; serology positive for HIV, hepatitis B or C \[HBV antigen S positive, acute HBsAg and IgM antiHBc Chronic HCV antibody HCV, HCV RNA- acute: HCV RNA (PCR)\].
• History or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine, methadone, or the ATRIGEL Delivery System.
• Donation of more than 250 mL of blood or plasma, or participation in another clinical trial, within 30 days prior to signing of the informed consent document for this study.
• Currently (during past 30 days from the signing of the informed consent document) engaged in opioid agonist, partial agonist, or antagonist treatment, or require on-going prescription or over-the-counter medications that are clinically relevant P450 3A4 inducers or inhibitors \[azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. erythromycin),\].
• Reporting taking buprenorphine within 30 days of screening.
• Significant traumatic injury, major surgery or open biopsy within the prior 4 weeks.
• Subjects who have been previously excluded from participation or previously enrolled into the study.
• Subjects who are unable, in the opinion of the Principal Investigator and/or the medically responsible physician, to comply fully with the study requirements.
• Subjects who have participated in another investigational product trial within 30 days of screening.

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (1)

Scientific Clinical Research

Fort Lauderdale, Florida, 33301, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: May 9, 2016
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 9, 2016

Record last verified: 2016-05

Locations

US (1)