INDV-6001 Multiple-Dose Pharmacokinetic Study

An Open-label, Multicentre Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Repeated Doses of INDV-6001 in Adults With Moderate to Severe Opioid Use Disorder

This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).

The current study will evaluate the pharmacokinetics (PK), safety, and tolerability of INDV-6001 following multiple doses in participants with OUD to select optimum dosing regimens for future studies. Prior to receiving INDV-6001, participants will be stabilised on 12-16 mg of transmucosal (TM) BUP (SUBOXONE®) or will transition from a 100-mg monthly maintenance dose of SC extended-release BUP (SUBLOCADE®). This study will also evaluate the use of alternative injection sites (thigh, back of upper arm), which may be desirable in this patient population for the anticipated extended durations of treatment.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Opioid Use Disorder
• Intervention / Treatment: Drug: INDV-6001; Drug: Suboxone; Drug: Sublocade

Detailed Description

Study Cohorts:

There are multiple cohorts (1, 2, 3, 4 and 7) testing varying dose strengths and frequencies of INDV-6001 in participants who are not receiving long-acting treatment for OUD. Up to 15 participants from each of the Cohorts 1, 2, 3, and 4 will enrol into Cohorts 1a, 2a, 3a, and 4a, respectively.

Study Periods:

Screening Period: from the Screening Visit until prior to the first SUBOXONE or SUBLOCADE dose as a part of this study Pre-Investigational Medicinal Product (IMP) Period: from the first SUBOXONE or SUBLOCADE dose as a part of this study until prior to the first INDV-6001 dose IMP Period: from the first INDV-6001 dose until the SUBLOCADE injection (Cohorts 3a and 4a only) or until the end of the study (EOS; all remaining cohorts) Post-IMP Period: (Cohorts 3a and 4a only) from the SUBLOCADE injection until EOS

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
  • Florida
    • Miami Lakes, Florida, United States, 33016
      • Innovative Clinical Research, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Chicago Clinical Research Institute Inc.
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Hassman Research Institute (Cenexel HRI - Marlton)
  • New York
    • Staten Island, New York, United States, 10314
      • Richmond Behavioral Associates
  • Ohio
    • Dayton, Ohio, United States, 45417
      • Midwest Clinical Research
  • Texas
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research, LLC
    • Houston, Texas, United States, 77043
      • Memorial Hermann Village
    • Richardson, Texas, United States, 75080
      • Pillar Clinical Research
  • Utah
    • Bountiful, Utah, United States, 84010
      • Progressive Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 600 mg on Day 8, Day 92, and Day 176)	Drug: INDV-6001; Extended-release subcutaneous injection; Drug: Suboxone; Oral sublingual film
Experimental: Cohort 2; SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 600 mg on Day 8, Day 64, Day 120, and Day 176)	Drug: INDV-6001; Extended-release subcutaneous injection; Drug: Suboxone; Oral sublingual film
Experimental: Cohort 3; SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, 600 mg Day 8, followed by 250 mg on Day 15, Day 43, Day 71, and Day 99)	Drug: INDV-6001; Extended-release subcutaneous injection; Drug: Suboxone; Oral sublingual film
Experimental: Cohort 4; SUBOXONE 12-16 mg once daily (to continue through Day 7), followed by INDV-6001 (600 mg Day 1, followed by 100 mg on Day 8, Day 36, Day 64, and Day 92)	Drug: INDV-6001; Extended-release subcutaneous injection; Drug: Suboxone; Oral sublingual film
Experimental: Cohort 1a; In Cohort 1, up to 15 participants who reach Day 260 will be enrolled into Cohort 1a. Participants in Cohort 1a will receive an additional injection of INDV-6001 600 mg in the back of the upper arm on Day 260.	Drug: INDV-6001; Extended-release subcutaneous injection
Experimental: Cohort 2a; In Cohort 2, up to 15 participants who reach Day 232 will be enrolled into Cohort 2a. Participants in Cohort 2a will receive an additional injection of INDV-6001 600 mg in the thigh on Day 232.	Drug: INDV-6001; Extended-release subcutaneous injection
Experimental: Cohort 3a; In Cohort 3, up to 15 participants who reach Day 127 will be enrolled into Cohort 3a. Participants in Cohort 3a will receive an injection of SUBLOCADE 300 mg (abdomen) on Day 127.	Drug: Sublocade; Extended-release subcutaneous injection
Experimental: Cohort 4a; In Cohort 4, up to 15 participants who reach Day 120 will be enrolled in Cohort 4a. Participants in Cohort 4a will receive an injection of SUBLOCADE 100 mg (abdomen) on Day 120.	Drug: Sublocade; Extended-release subcutaneous injection
Experimental: Cohort 7; Participants in Cohort 7 who are new to BUP treatment will undergo rapid induction with SUBLOCADE 300 mg (per product labelling) in the abdomen on Day 1 following an initial dose of SUBOXONE (eg, 4 mg). All participants in Cohort 7 will receive: SUBLOCADE 300 mg (abdomen) on Day 1 and Day 8, SUBLOCADE 100 mg (abdomen) on Day 36, and 600mg INDV-6001 on Day 64.	Drug: INDV-6001; Extended-release subcutaneous injection; Drug: Suboxone; Oral sublingual film; Drug: Sublocade; Extended-release subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 injection in the abdomen	AUCtau for Cohorts 1-4	Up to 260 days
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection in the abdomen	Cmax for Cohorts 1-4	Up to 260 days
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 injection in the abdomen	Tmax for Cohorts 1-4	Up to 260 days
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 injection in the abdomen	Cmin for Cohorts 1-4	Up to 260 days
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 injection in the abdomen	Ctrough for Cohorts 1-4	Up to 260 days
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 injection in the abdomen	Cavg for Cohorts 1-4	Up to 260 days
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 injection	% fluctuation for Cohorts 1-4	Up to 260 days
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location	AUCtau for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]	Up to 168 days [24 weeks]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location	Cmax for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]	Up to 168 days [24 weeks]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location	Tmax for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]	Up to 168 days [24 weeks]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location	Cmin for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]	Up to 168 days [24 weeks]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location	Ctrough for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]	Up to 168 days [24 weeks]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location	Cavg for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]	Up to 168 days [24 weeks]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location	% fluctuation for Cohort 1a [Day 260 injection in the back of the upper arm] Vs Cohort 1 [Day 176 Injection in the abdomen]	Up to 168 days [24 weeks]
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location	AUCtau for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]	Up to 128 days [16 weeks]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location	Cmax for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]	Up to 128 days [16 weeks]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location	Tmax for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]	Up to 128 days [16 weeks]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location	Cmin for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]	Up to 128 days [16 weeks]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location	Ctrough for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]	Up to 128 days [16 weeks]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location	Cavg for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]	Up to 128 days [16 weeks]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location	% fluctuation for Cohort 2a [Day 232 injection in the Thigh] Vs Cohort 2 [Day 176 injection in the abdomen]	Up to 128 days [16 weeks]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the safety and tolerability of INDV-6001 injection	Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs leading to discontinuation, fatal TEAEs, and AEs of special interest (AESIs) for All Cohorts	Up to 260 days
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen	AUCtau for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen	Cmax for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen	Tmax for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen	Cmin for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen	Ctrough for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen	Cavg for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 250mg injection in the abdomen Vs SUBLOCADE 300mg injection in the abdomen	%fluctuation for Cohort 3 [Day 99 250mg INDV-6001 injection in the abdomen] Vs Cohort 3a [Day 127 300mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	AUCtau for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	Cmax for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	Tmax for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	Cmin for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	Ctrough for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	Cavg for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	% fluctuation for Cohort 4 [Day 92 250mg INDV-6001 injection in the abdomen] Vs Cohort 4a [Day 120 100mg SUBLOCADE injection in the abdomen]	Up to 56 days [8 weeks]
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	AUCtau for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]	Up to 112 days [16 weeks]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	Cmax for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]	Up to 112 days [16 weeks]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	Tmax for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]	Up to 112 days [16 weeks]
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	Cmin for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]	Up to 112 days [16 weeks]
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	Ctrough for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]	Up to 112 days [16 weeks]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	Cavg for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]	Up to 112 days [16 weeks]
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen	% fluctuation for Cohort 7 [Day 64 600mg INDV-6001 injection in the abdomen] Vs [Day 36 100mg SUBLOCADE injection in the abdomen]	Up to 112 days [16 weeks]

Collaborators and Investigators

• Sponsor: Indivior Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Actual): January 21, 2026
• Study Completion (Actual): January 21, 2026

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Drug Combinations; Naloxone; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Sublocade
• Other Study ID Numbers: INDV-6001-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No