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Eligibility

Eligible Ages

Between 18 Years and 65 Years

Eligible Genders

All

Accepts Healthy Volunteers

No

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)