Overview

This trial is active, not recruiting.

Conditions opioid use disorder, chronic pain
Treatment cam2038
Phase phase 2
Sponsor Braeburn Pharmaceuticals
Start date February 2015
End date March 2017
Trial size 50 participants
Trial identifier NCT02710526, HS-15-549

Summary

Phase II, open label, randomized, two treatment group study designed to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous administrations of CAM2038.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at multiple injection sites
cam2038 Buprenorphine
Long-Acting Subcutaneous Injectable Depot of Buprenorphine
(Experimental)
Group 2: 128 mg of CAM2038 subcutaneous monthly injection in the buttocks
cam2038 Buprenorphine
Long-Acting Subcutaneous Injectable Depot of Buprenorphine

Primary Outcomes

Measure
AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm.
time frame: 7 weeks
Css,av (average plasma concentration during a dosing interval at steady state) for each injection site
time frame: 7 weeks
Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site.
time frame: 7 weeks
tss,max (time to maximum concentration at steady state) for each injection site
time frame: 7 weeks
norbuprenorphine/buprenorphine ratios for Area Under the Curve at steady state and at maximum concentration at steady state at each injection site location
time frame: 7 weeks
Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)
time frame: 4 months
Average steady state concentration
time frame: 4 months
Maximum steady state concentration
time frame: 4 months
time to maximum concentration at steady state
time frame: 4 months
Css, 28days (observed plasma concentration 28 days after administration at steady state)
time frame: 4 months
norbuprenorphine/buprenorphine ratios for Area Under the Curve at steady state and at maximum concentration at steady state
time frame: 4 months

Secondary Outcomes

Measure
Quantify the number of adverse events for both weekly and monthly CAM2038
time frame: 4 months

Eligibility Criteria

Male or female participants from 19 years up to 65 years old.

Inclusion Criteria: 1. Subject must provide written informed consent prior to the conduct of any study related procedures. 2. Male or non pregnant, non lactating female subject, aged 19 to 65 years, inclusive. 3. Body mass index between 19 and 35 kg/m2, inclusive. 4. Current diagnosis of moderate to severe opioid use disorder (according to the DSM 5) or past medical history of opioid use disorder currently being treated with SL BPN. 5. Subject must be taking SL BPN (Subutex® equivalent) 24 mg daily for at least 30 days prior to Screening. 6. Subject has a history of moderate to severe chronic non cancer pain. Exclusion Criteria: 1. Individuals meeting DSM 5 substance use disorder criteria for alcohol, benzodiazepines, central nervous system (CNS) stimulants, or other drugs of abuse (excluding caffeine, tobacco or THC/marijuana). 2. Any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12 lead electrocardiogram and laboratory evaluations 3. Use (therapeutic or non therapeutic) of opioids other than SL BPN. 4. Aspartate aminotransferase (AST) levels > 3 X the upper limit of normal, alanine aminotransferase (ALT), levels > 3 X the upper limit of normal, total bilirubin > 1.5 X the upper limit of normal, or creatinine > 1.5 X upper limit of normal. 5. Pregnant or lactating or planning to become pregnant during the study. 6. Diagnosis of, or currently under investigation for, fibromyalgia, complex regional pain syndrome, neurogenic claudication due to spinal stenosis, spinal cord compression, acute nerve root compression, severe or progressive lower extremity weakness or numbness. 7. History of chemotherapy or confirmed malignancy (except basal cell or squamous carcinoma of the skin) within the past 2 years. 8. Clinically significant history of, or current evidence for, suicidal ideation or those who are actively suicidal, as based on the Columbia Suicide Severity Rating Scale (C SSRS; grade 4 or 5). 9. Clinically significant history of major depressive disorder that is poorly controlled with medication. 10. Hypersensitivity or allergy to BPN or other opioids, or excipients of CAM2038. 11. Exposure to any investigational drug within the 4 weeks prior to Screening. 12. Participants with a clinically significant history of risk factors of Torsades de Pointes and any existing ventricular tachyarrhythmias such as bigeminy, trigeminy, heart failure, hypokalemia, family history of Long QT Syndrome. 13. Requires current use of agents that have the potential for prolonging the QTc interval. 14. Requires current use of agents that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) such as some azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir).

Additional Information

Official title Phase II, Open Label, Randomized, Two Treatment Groups, Study Assessing Pharmacokinetics After Administration of the Once Weekly and Once Monthly, Long Acting Subcutaneous Injection of CAM2038 in Opioid Dependent Subjects With Chronic Pain
Description This is a phase II, open label, randomized, two treatment group study designed to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous administrations of CAM2038 weekly at different injection sites and to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine after repeated subcutaneous administration of CAM2038 monthly in opioid dependent subjects with a history of chronic non cancer pain. The study will involve three phases: Screening, Treatment, and Follow up.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Braeburn Pharmaceuticals.