INDV-6001 Multiple-Dose Pharmacokinetic Study

NCT06576843 | Completed Phase 2 FDA Drug

• 1 other identifier: INDV-6001-201
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Moderate to Severe Opioid Use Disorder

Outcome Measures

Primary Outcomes (21)

• 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 Outcomes (22)

• Assessment of the safety and tolerability of INDV-6001 injection

  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

  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

  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

  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

  Up to 56 days [8 weeks]

Study Arms (9)

Cohort 1

EXPERIMENTAL

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; Drug: Suboxone

Cohort 2

EXPERIMENTAL

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; Drug: Suboxone

Cohort 3

EXPERIMENTAL

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; Drug: Suboxone

Cohort 4

EXPERIMENTAL

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; Drug: Suboxone

Cohort 1a

EXPERIMENTAL

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

Cohort 2a

EXPERIMENTAL

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

Cohort 3a

EXPERIMENTAL

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

Cohort 4a

EXPERIMENTAL

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

Cohort 7

EXPERIMENTAL

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; Drug: Suboxone; Drug: Sublocade

Interventions

INDV-6001 DRUG

Extended-release subcutaneous injection

Cohort 1; Cohort 1a; Cohort 2; Cohort 2a; Cohort 3; Cohort 4; Cohort 7

Suboxone DRUG

Oral sublingual film

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 7

Sublocade DRUG

Extended-release subcutaneous injection

Cohort 3a; Cohort 4a; Cohort 7

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in any cohort open to enrolment in the study only if all of the following criteria apply:
• Has signed the ICF and have the ability to understand and comply with the requirements and restrictions listed therein
• Is an adult (male or female) between the ages of 18 and 65 years, inclusive, at the time of signing the ICF
• Has a BMI of ≥18.0 to ≤33.0 kg/m2
• 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
• Agrees not to take any BUP-containing products, other than those administered for the current study, throughout the duration of the study
• 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:
• 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
• Permanently sterilised (eg, bilateral tubal occlusion, bilateral tubal ligation, complete hysterectomy, bilateral salpingectomy, bilateral oophorectomy)

You may not qualify if:

• Has current diagnosis or medical condition, other than OUD, requiring chronic opioid treatment
• 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
• Has an injection area unsuitable for SC injections (eg, nodules, scarring, lesions, excessive pigment) in the areas designated for possible injection in the study
• 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
• 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
• 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
• Has known family history of congenital QT prolongation or sudden unexplained death
• 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 \[eg, erythromycin\])
• 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
• 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
• Has active hepatitis B or C as evidenced by positive serology and PCR test confirmation
• 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)
• Has serum creatinine \>1.5 × ULN or estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2 by CKD-EPI formula
• Has known allergy or hypersensitivity to BUP, any excipients of INDV-6001, SUBOXONE, or SUBLOCADE
• 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

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (11)

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Innovative Clinical Research, Inc.

Miami Lakes, Florida, 33016, United States

Location

Chicago Clinical Research Institute Inc.

Chicago, Illinois, 60607, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

Hassman Research Institute (Cenexel HRI - Marlton)

Marlton, New Jersey, 08053, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

Location

Midwest Clinical Research

Dayton, Ohio, 45417, United States

Location

Insite Clinical Research, LLC

DeSoto, Texas, 75115, United States

Location

Memorial Hermann Village

Houston, Texas, 77043, United States

Location

Pillar Clinical Research

Richardson, Texas, 75080, United States

Location

Progressive Clinical Research

Bountiful, Utah, 84010, United States

Location

MeSH Terms

Interventions

Buprenorphine, Naloxone Drug Combination; Sublocade

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: September 17, 2024
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (11)