INDV-6001 Multiple-Dose Pharmacokinetic Study

Launched by INDIVIOR INC. · Aug 27, 2024

Keywords

ClinConnect Summary

The INDV-6001 Multiple-Dose Pharmacokinetic Study is a clinical trial aimed at understanding how the new medication INDV-6001 works in the body when given multiple times to adults with moderate to severe opioid use disorder. The researchers want to determine the safety and how well participants tolerate this treatment, which could help in deciding the best dosages for future studies. Participants will first be stabilized on a medication called buprenorphine (either SUBOXONE® or SUBLOCADE®) before starting the study treatment. The trial will also explore giving the medication through different injection sites, like the thigh or back of the upper arm, which might be more comfortable for patients.

To be eligible for the study, participants must be between 18 and 65 years old, with a body weight that falls within a specific range, and actively seeking treatment for opioid use disorder. They should also be currently using buprenorphine or have a documented history of opioid use disorder. Participants will receive close monitoring throughout the study, and those who join will be helping to advance treatment options for others facing similar challenges. It’s important for potential participants to be aware of specific health criteria that could disqualify them from joining, such as having certain medical conditions or using other treatments for opioid use disorder.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Participants are eligible to be included in any cohort open to enrolment in the study only if all of the following criteria apply:
• • 1. Has signed the ICF and have the ability to understand and comply with the requirements and restrictions listed therein
• • 2. Is an adult (male or female) between the ages of 18 and 65 years, inclusive, at the time of signing the ICF
• • 3. Has a BMI of ≥18.0 to ≤33.0 kg/m2
• • 4. Is seeking MOUD and currently meets or has documented history of moderate or severe OUD as per DSM-5 criteria. For Cohorts 1-4 only: can be dose-adjusted to 12 to 16 mg SUBOXONE QD or currently taking TM BUP for OUD and can be dose-adjusted to 12 to 16 mg SUBOXONE QD
• • 5. Agrees not to take any BUP-containing products, other than those administered for the current study, throughout the duration of the study
• 6. If a woman of childbearing potential, not pregnant or lactating and agrees to follow contraception guidelines per protocol; if a women of non-childbearing potential (WONCBP), is:
• • 1. Postmenopausal (defined as no menses for 12 months without an alternative medical cause and confirmed by high FSH level of \>30 mIU/mL in women not using hormonal contraception or hormonal replacement therapy) or
• • 2. Permanently sterilised (eg, bilateral tubal occlusion, bilateral tubal ligation, complete hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
• • 7. If a man, agrees to follow contraception guidelines per protocol 5.2 Exclusion Criteria
• A participant will not be eligible for inclusion in this study if any of the following criteria apply:
• • 1. Has current diagnosis or medical condition, other than OUD, requiring chronic opioid treatment
• • 2. Has a 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 an injection area unsuitable for SC injections (eg, nodules, scarring, lesions, excessive pigment) in the areas designated for possible injection in the study
• • 4. Is currently using another MOUD treatment other than TM BUP (eg, SUBOXONE) or has had prior treatment with any long-acting injectable form of a BUP-containing product in the past 18 months (or if 18-24 months with a positive UDS) prior to consent; treatment with oral naltrexone or methadone products within 14 days prior to consent (or positive UDS for methadone at Screening); or treatment with depot naltrexone within the 3 months prior to consent
• • 5. Has had significant traumatic injury or major surgical procedure (as defined by the investigator) within 30 days prior to the first dose of INDV-6001 or still recovering from such prior injury or surgery
• • 6. Has congenital long QT syndrome, history of prolonged QT in the 3 months prior to screening, or a corrected QT interval (Fridericia's - QTcF) \>450 msec (male) or \>470 msec (female), or history of risk factors for Torsades de Pointes. Has known personal history of taking Class IA antiarrhythmic medications (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (eg, sotalol, amiodarone) or other mediations that prolong the QT interval
• • 7. Has known family history of congenital QT prolongation or sudden unexplained death
• • 8. Is currently taking (within the 30 days prior to signing the ICF) prescription or OTC medications that are clinically relevant moderate or strong cytochrome P450 (CYP) 3A4 or CYP 2C8 inducers or inhibitors (eg, rifampin, azole antifungals \[eg, ketoconazole\], macrolide antibiotics \[eg, erythromycin\])
• • 9. Has a history of suicidal ideation within 30 days prior to providing written informed consent (evidenced by answering yes to either question 1 or 2 on the C-SSRS) or a history of a suicide attempt in the 6 months prior to consent
• • 10. Has any active medical condition (including organ disease), psychiatric illness, social/legal situation (including court order requiring treatment for OUD), or concurrent medication/treatment that may compromise participant safety, interfere with study endpoints, limit compliance with study requirements, or compromise the ability of the participant to provide written informed consent
• • 11. Has active hepatitis B or C as evidenced by positive serology and PCR test confirmation
• • 12. Has total bilirubin ≥1.5 × ULN (with direct bilirubin \>20% of total bilirubin), ALT ≥3 × ULN, AST ≥3 × ULN, or INR \>1.5 × ULN at Screening)
• • 13. Has serum creatinine \>1.5 × ULN or estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2 by CKD-EPI formula
• • 14. Has known allergy or hypersensitivity to BUP, any excipients of INDV-6001, SUBOXONE, or SUBLOCADE
• • 15. Is currently participating in another interventional clinical study, and/or has been treated with investigational product INDV-2000 within 1 month prior to Screening Visit, or another investigational agent within 3 months prior to Screening Visit
• • 16. Is currently being treated with medications contraindicated for use with BUP as per local prescribing information
• • 17. Has donated more than 500 mL of blood within the past 3 months prior to consent
• • 18. 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 (eg, site staff or Indivior employee)