Evaluation of Buprenorphine Extended-Release Subcutaneous Injection at Alternative Injection Locations

Sponsor
Indivior Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05704543
Collaborator
(none)
80
4
8

Study Details

Study Description

Brief Summary

Extended-release buprenorphine (SUBLOCADE®) injection is currently approved for subcutaneous administration in 4 different quadrants of the abdomen for treatment of opioid use disorder (OUD). Injection locations are rotated to minimize irritation. Having 1 or more alternate injection sites is desirable for patients who may be taking SUBLOCADE for extended durations, based upon clinical response.

The primary objective of this study is to assess the relative bioavailability of extended-release buprenorphine when administered at alternative injection locations (test treatments), in comparison to the abdomen (reference treatment).

Condition or Disease Intervention/Treatment Phase
  • Drug: Buprenorphine Extended-Release Injection
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-Dose Study to Evaluate the Relative Bioavailability, Safety, and Tolerability of SUBLOCADE at Alternative Injection Locations in Adults
Anticipated Study Start Date :
Feb 28, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Extended-release Buprenorphine: Abdomen

Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.

Drug: Buprenorphine Extended-Release Injection
Administered as a subcutaneous injection.
Other Names:
  • SUBLOCADE®
  • Experimental: Extended-release Buprenorphine: Upper Arm

    Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.

    Drug: Buprenorphine Extended-Release Injection
    Administered as a subcutaneous injection.
    Other Names:
  • SUBLOCADE®
  • Experimental: Extended-release Buprenorphine: Buttocks

    Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.

    Drug: Buprenorphine Extended-Release Injection
    Administered as a subcutaneous injection.
    Other Names:
  • SUBLOCADE®
  • Experimental: Extended-release Buprenorphine: Thigh

    Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.

    Drug: Buprenorphine Extended-Release Injection
    Administered as a subcutaneous injection.
    Other Names:
  • SUBLOCADE®
  • Outcome Measures

    Primary Outcome Measures

    1. Area Under the Concentration-time Curve from Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine [Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29]

    2. Maximum Observed Plasma Concentration (Cmax) of Buprenorphine [Day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on Days 4, 6, 8, 11, 15, 18, 22, 25, and 29]

    Secondary Outcome Measures

    1. Participants with Treatment-emergent Adverse Events [28 days]

    2. Number of Participants with Treatment-emergent Adverse Events Identified as Injection Site Reactions [28 days]

    3. Number of Participants with Treatment-emergent Serious Adverse Events [28 days]

    4. Injection Site Grading [Day 1 at 10 minutes and 2 hours post dosing]

      Injection sites will be assessed for pain, tenderness, erythema/redness, induration, or swelling. Local injection site tolerability will be assigned a severity grade, including none (grade 0), mild (grade 1), moderate (grade 2), severe (grade 3), or potentially life-threatening (grade 4) utilizing the Injection Site Grading Scale.

    5. Injection Site Pain [Day 1 at 1, 5, 10, 15, and 30 minutes post dosing]

      Measured on a 100 mm visual analog scale (VAS), where 0 represents no pain and 100 represents maximum pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Signed the informed consent form (ICF) and have the ability to comply with the requirements and restrictions listed therein.

    2. Sex: male or female.

    3. Between the ages of 18 and 65 years inclusive, at the time of signing the ICF.

    4. Currently meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for moderate or severe opioid use disorder (OUD), or documented history of moderate to severe OUD and receiving/stabilized on medicine for opioid use disorder (MOUD).

    5. Body mass index: ≥ 18.0 to ≤ 33.0 kg/m^2.

    6. New to treatment and seeking MOUD, or currently prescribed transmucosal (TM) buprenorphine (BUP) for OUD at the dose of 12 mg daily or can dose adjust to 12 mg daily.

    7. Agree not to take any BUP-containing products, other than those administered for the current study, throughout the duration of the study.

    Exclusion Criteria:
    1. Has current diagnosis, other than OUD, requiring chronic opioid treatment.

    2. Has concurrent primary substance use disorder, as defined by DSM-5 criteria, other than opioid, tobacco, cannabis, or mild to moderate alcohol use disorders.

    3. Has target areas unsuitable for subcutaneous injections or evaluation of injections site (eg, nodules, scarring, lesions, excessive pigment) in the areas designated for possible injection in the study.

    4. Has had significant traumatic injury or major surgical procedure (as defined by the investigator) within 30 days prior to the first dose of SUBLOCADE or still recovering from prior such injury or surgery.

    5. Known personal and/or family history of congenital QT prolongation, or taking Class IA antiarrhythmic medications (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (eg, sotalol, amiodarone) or other medications that prolong the QT interval. Known family history of sudden unexplained death.

    6. Currently taking (within the 30 days prior to signing the ICF) prescription or over-the-counter medications that are clinically relevant CYP 3A4 or CYP 2C8 inducers or inhibitors (eg, rifampin, azole antifungals [eg, ketoconazole], macrolide antibiotics [eg, erythromycin]).

    7. Has history of suicidal ideation within 30 days prior to informed consent or history of a suicide attempt in the 6 months prior to informed consent.

    8. Has any active medical condition, or psychiatric illness, or social/legal situation (including court order requiring treatment for OUD), or organ disease, or concurrent medication/treatment that may compromise participant safety, interfere with study endpoints, or limit compliance with study requirements, or compromise the ability of the participant to provide written informed consent.

    9. Moderate or severe hepatic impairment (Child-Pugh B or C).

    10. Has known allergy or hypersensitivity to BUP or any component of the ATRIGEL Delivery System.

    11. Concurrent or has had prior treatment with any BUP long-acting injectable product (eg, SUBLOCADE) in the past 3 years prior to consent; or treatment with depot naltrexone within the 3 months prior to consent.

    12. Treatment with another investigational agent within 30 days prior to Screening or enrollment in another clinical study (except for an observational study).

    13. Concurrent treatment with medications contraindicated for use with BUP as per local prescribing information.

    14. Is a member of site staff, has a financial interest in Indivior, or is an immediate family member of anyone directly involved in the study (ie, site staff or Indivior employee).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Indivior Inc.

    Investigators

    • Study Director: Global Director Clinical Development, Indivior Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Indivior Inc.
    ClinicalTrials.gov Identifier:
    NCT05704543
    Other Study ID Numbers:
    • INDV-6000-405
    First Posted:
    Jan 30, 2023
    Last Update Posted:
    Feb 6, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Indivior Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 6, 2023