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Trial record 2 of 655 for:    cam2038

Phase II Pharmacokinetics Study of CAM2038

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ClinicalTrials.gov Identifier: NCT02710526
Recruitment Status : Completed
First Posted : March 16, 2016
Results First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Braeburn Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Chronic Pain Drug: CAM2038 Phase 2

Detailed Description:
This is a phase II, open label, partially randomized, three treatment group study designed to evaluate the steady state pharmacokinetics of buprenorphine and norbuprenorphine following repeated subcutaneous administrations of CAM2038 weekly and monthly 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-label, Partially Randomized, 3 Treatment Groups, Multi-Site Study Assessing Pharmacokinetics After Administration of the Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injectable Depot of Buprenorphine (CAM2038) at Different Injection Sites in Opioid-Dependent Subjects With Chronic Pain
Study Start Date : February 2015
Actual Primary Completion Date : May 17, 2017
Actual Study Completion Date : July 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: 32 mg CAM2038 weekly
Group 1, 32 mg of CAM2038 subcutaneous weekly injection at multiple injection sites
Drug: CAM2038
Long-Acting Subcutaneous Injectable Depot of Buprenorphine
Other Name: Buprenorphine

Experimental: 128 mg CAM2038 monthly injection
Group 2: 128 mg of CAM2038 subcutaneous monthly injection in the buttocks
Drug: CAM2038
Long-Acting Subcutaneous Injectable Depot of Buprenorphine
Other Name: Buprenorphine

Experimental: 160 mg CAM2038 monthly injection
Group 3: 24mg sublingual BPN for the first 7 days, and then 160 mg of CAM2038 subcutaneous monthly injection in the buttocks starting on Day 8.
Drug: CAM2038
Long-Acting Subcutaneous Injectable Depot of Buprenorphine
Other Name: Buprenorphine




Primary Outcome Measures :
  1. 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 for the Evaluable Pharmacokinetic (PKEVAL) Population [ Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. ]
    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-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population

  2. Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population [ Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. ]
    Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population

  3. Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. [ Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. ]
    Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine

  4. Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site [ Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. ]
    Tss,max (time to maximum concentration at steady state) for each injection site-buprenorphine

  5. Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Buprenorphine [ Time Frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 ]
    Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Buprenorphine for Pharmacokinetic Population

  6. Average Steady State Concentration-Buprenorphine [ Time Frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 ]
    Average steady state concentration-Buprenorphine-Pharmacokinetic Population

  7. Maximum Steady State Concentration-Buprenorphine [ Time Frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 ]
    Maximum steady state concentration-BuprenorphinePharmacokinetic (PK) Population

  8. Time to Maximum Concentration at Steady State-Buprenorphine [ Time Frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 ]
    Time to maximum concentration at steady state-Buprenorphine Pharmacokinetic (PK) Population

  9. Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State [ Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. ]
    Norbuprenorphine/buprenorphine ratios at maximum concentration at steady state Evaluable Pharmacokinetic (PKEVAL) Population

  10. 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: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. ]
    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-Norbuprenorphine Evaluable Pharmacokinetic (PKEVAL) Population

  11. Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site [ Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. ]
    Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population

  12. Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site. [ Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. ]
    Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population

  13. Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site [ Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. ]
    Tss,max (time to maximum concentration at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population

  14. Norbuprenorphine/Buprenorphine Ratios for Area Under the Curve at Steady State [ Time Frame: PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7. ]
    Norbuprenorphine/buprenorphine ratios for Area Under the Curve at steady state Evaluable Pharmacokinetic (PKEVAL) Population

  15. Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Norepinephrine [ Time Frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 ]
    Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Norepinephrine-Pharmacokinetic (PK) Population

  16. Average Steady State Concentration-Norbuprenorphine [ Time Frame: PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4 ]
    Average steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population

  17. Maximum Steady State Concentration-Norbuprenorphine [ Time Frame: PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7 ]
    Maximum steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population

  18. Time to Maximum Concentration at Steady State-Norbuprenorphine [ Time Frame: PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7 ]
    Time to maximum concentration at steady state-Norbuprenorphine-Pharmacokinetic (PK) Population


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038 [ Time Frame: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3 ]
    Number of Participants with Adverse Events for Both weekly and monthly CAM2038-Safety Population


Other Outcome Measures:
  1. Summary of Average Daily Pain by Week (ITT Population) [ Time Frame: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3 ]
    Summary of Average Daily Pain, using an 11-point Numerical Rating Scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable. (ITT Population)

  2. Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests [ Time Frame: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3 ]
    Number of Participants with confirmed Opiate Independence as confirmed by Negative Urine Toxicology Tests-ITT Population

  3. Subject-rated Worst Daily Pain [ Time Frame: 99 days for Group 1, 162 days for Group 2, 127 days for Group 3 ]
    Subject-rated worst daily pain, using an 11-point numerical rating scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects-Safety Population. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (Group 1 and Group 2) or ≥24 mg (Group 3) daily for at least 30 days prior to Screening.
  6. Subject has a history of moderate to severe chronic non cancer pain.
  7. Male and female subjects of childbearing potential must be willing to use a reliable method of contraception during the entire study (Screening visit to Follow-up phone call).
  8. Subject must be willing and able to comply with all study procedures and requirements.

Exclusion Criteria:

  1. Individuals meeting DSM-V 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 (ECG; Fridericia's corrected QT interval [QTcF] ≥450 msec. for males or ≥470 msec. for females), and laboratory evaluations (including hematology, clinical chemistry, urinalysis at Screening), in the opinion of the Investigator.
  3. Significant symptoms, medical conditions, or other circumstances which, in the opinion of the Investigator, would preclude compliance with the protocol, adequate cooperation in the study or obtaining informed consent, or may prevent the subject from safely participating in study, including subjects who are at a risk for gastrointestinal obstruction or paralytic ileus or who have severe respiratory insufficiency, respiratory depression, airway obstruction, gastrointestinal motility disorders, biliary tract disease, severe hepatic insufficiency, planned surgery and prior treatment with monoamine oxidase inhibitors.
  4. Use (therapeutic or non-therapeutic) of opioids other than SL BPN.
  5. 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 on the Screening laboratory assessments, or other clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the subject from safely participating in study.
  6. Pregnant or lactating or planning to become pregnant during the study.
  7. 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.
  8. History of chemotherapy or confirmed malignancy (except basal cell or squamous carcinoma of the skin) within the past 2 years.
  9. 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).
  10. Clinically significant history of major depressive disorder that is poorly controlled with medication.
  11. Hypersensitivity or allergy to BPN or other opioids, or excipients of CAM2038.
  12. Exposure to any investigational drug within the 4 weeks prior to Screening.
  13. 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.
  14. On medications that have the potential for prolonging the QT interval or who may require such medications during the course of the study along with clinically significant abnormalities on screening electrocardiogram (ECG) readings as deemed by the investigator.
  15. 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).
  16. Intolerance to venipuncture and/or difficulty with venous access, as per the judgment of the Investigator/research staff.
  17. Is an employee of the Investigator or the study site, with direct involvement in the proposed study or other studies under the direction of the Investigator or study site, or is a family member of an employee or of the Investigator.
  18. Any pending legal action that could prohibit participation or compliance in the study.

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): NCT02710526


Locations
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United States, Alabama
Parkway Medical
Birmingham, Alabama, United States, 35215
United States, New Jersey
Hassman Research Institute
Berlin, New Jersey, United States, 08009
United States, Oklahoma
The Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, United States, 73112
Sponsors and Collaborators
Braeburn Pharmaceuticals
Investigators
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Principal Investigator: James Sullivan Parkway Medical Center
  Study Documents (Full-Text)

Documents provided by Braeburn Pharmaceuticals:
Statistical Analysis Plan  [PDF] December 16, 2016
Study Protocol  [PDF] October 5, 2016

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Responsible Party: Braeburn Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02710526    
Other Study ID Numbers: HS-15-549
First Posted: March 16, 2016    Key Record Dates
Results First Posted: April 30, 2020
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Buprenorphine
Chronic Pain
Pain
Neurologic Manifestations
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists