INDV-6001 Multiple-Dose Pharmacokinetic Study
- Conditions
- Moderate to Severe Opioid Use Disorder
- Interventions
- Registration Number
- NCT06576843
- Lead Sponsor
- Indivior Inc.
- 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.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 122
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1a INDV-6001 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. Cohort 2a INDV-6001 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. Cohort 3a Sublocade 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. Cohort 4a Sublocade 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. Cohort 7 INDV-6001 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. Cohort 7 Suboxone 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. Cohort 7 Sublocade 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. Cohort 3 INDV-6001 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) Cohort 3 Suboxone 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) Cohort 4 INDV-6001 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) Cohort 4 Suboxone 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) Cohort 1 INDV-6001 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) Cohort 1 Suboxone 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) Cohort 2 INDV-6001 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) Cohort 2 Suboxone 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)
- Primary Outcome Measures
Name Time Method Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location Up to 128 days [16 weeks] Cmin for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
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 Up to 128 days [16 weeks] Ctrough for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location Up to 128 days [16 weeks] Cavg for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
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 Up to 128 days [16 weeks] % fluctuation for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
Steady-state area under the plasma concentration-time curve over the dosing interval (AUCtau) of buprenorphine following INDV-6001 injection in the abdomen Up to 260 days AUCtau for Cohorts 1-4
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection in the abdomen Up to 260 days Cmax for Cohorts 1-4
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 injection in the abdomen Up to 260 days Tmax for Cohorts 1-4
Steady-state minimum plasma concentration over a dosing interval (Cmin) of buprenorphine following INDV-6001 injection in the abdomen Up to 260 days Cmin for Cohorts 1-4
Steady-state plasma concentration measured at the end of the dosing interval (Ctrough) of buprenorphine following INDV-6001 injection in the abdomen Up to 260 days Ctrough for Cohorts 1-4
Steady-state average plasma concentration over the dosing interval (Cavg) of buprenorphine following INDV-6001 injection in the abdomen Up to 260 days Cavg for Cohorts 1-4
Steady-state ratio of peak to trough plasma concentrations over a dosing interval (% fluctuation) of buprenorphine following INDV-6001 injection Up to 260 days % fluctuation for Cohorts 1-4
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 Up to 168 days [24 weeks] AUCtau for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection in the back of the upper arm Vs abdomen injection location Up to 168 days [24 weeks] Cmax for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
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 Up to 168 days [24 weeks] Tmax for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
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 Up to 168 days [24 weeks] Cmin for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
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 Up to 168 days [24 weeks] Ctrough for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
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 Up to 168 days [24 weeks] Cavg for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
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 Up to 168 days [24 weeks] % fluctuation for Cohort 1a \[Day 260 injection in the back of the upper arm\] Vs Cohort 1 \[Day 176 Injection in the abdomen\]
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 Up to 128 days [16 weeks] AUCtau for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location Up to 128 days [16 weeks] Cmax for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
Steady-state time to attain the maximum observed plasma concentration (Tmax) of buprenorphine following INDV-6001 injection in the Thigh Vs abdomen injection location Up to 128 days [16 weeks] Tmax for Cohort 2a \[Day 232 injection in the Thigh\] Vs Cohort 2 \[Day 176 injection in the abdomen\]
- Secondary Outcome Measures
Name Time Method 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] Cmax for Cohort 3 \[Day 99 250mg INDV-6001 injection in the abdomen\] Vs Cohort 3a \[Day 127 300mg SUBLOCADE injection in the abdomen\]
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] Tmax for Cohort 3 \[Day 99 250mg INDV-6001 injection in the abdomen\] Vs Cohort 3a \[Day 127 300mg SUBLOCADE injection in the abdomen\]
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] Cmin for Cohort 3 \[Day 99 250mg INDV-6001 injection in the abdomen\] Vs Cohort 3a \[Day 127 300mg SUBLOCADE injection in the abdomen\]
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] AUCtau for Cohort 3 \[Day 99 250mg INDV-6001 injection in the abdomen\] Vs Cohort 3a \[Day 127 300mg SUBLOCADE injection in the abdomen\]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 100mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen Up to 56 days [8 weeks] Cmax for Cohort 4 \[Day 92 250mg INDV-6001 injection in the abdomen\] Vs Cohort 4a \[Day 120 100mg SUBLOCADE injection in the abdomen\]
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 Up to 56 days [8 weeks] Tmax for Cohort 4 \[Day 92 250mg INDV-6001 injection in the abdomen\] Vs Cohort 4a \[Day 120 100mg SUBLOCADE injection in the abdomen\]
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 Up to 56 days [8 weeks] Cmin for Cohort 4 \[Day 92 250mg INDV-6001 injection in the abdomen\] Vs Cohort 4a \[Day 120 100mg SUBLOCADE injection in the abdomen\]
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 Up to 56 days [8 weeks] Ctrough for Cohort 3 \[Day 99 250mg INDV-6001 injection in the abdomen\] Vs Cohort 3a \[Day 127 300mg SUBLOCADE injection in the abdomen\]
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 Up to 56 days [8 weeks] Cavg for Cohort 3 \[Day 99 250mg INDV-6001 injection in the abdomen\] Vs Cohort 3a \[Day 127 300mg SUBLOCADE injection in the abdomen\]
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 Up to 56 days [8 weeks] %fluctuation for Cohort 3 \[Day 99 250mg INDV-6001 injection in the abdomen\] Vs Cohort 3a \[Day 127 300mg SUBLOCADE injection in the abdomen\]
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 Up to 56 days [8 weeks] AUCtau for Cohort 4 \[Day 92 250mg INDV-6001 injection in the abdomen\] Vs Cohort 4a \[Day 120 100mg SUBLOCADE injection in the abdomen\]
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 Up to 112 days [16 weeks] AUCtau for Cohort 7 \[Day 64 600mg INDV-6001 injection in the abdomen\] Vs \[Day 36 100mg SUBLOCADE injection in the abdomen\]
Steady-state maximum observed plasma concentration (Cmax) of buprenorphine following INDV-6001 600mg injection in the abdomen Vs SUBLOCADE 100mg injection in the abdomen Up to 112 days [16 weeks] Cmax for Cohort 7 \[Day 64 600mg INDV-6001 injection in the abdomen\] Vs \[Day 36 100mg SUBLOCADE injection in the abdomen\]
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 Up to 112 days [16 weeks] Tmax for Cohort 7 \[Day 64 600mg INDV-6001 injection in the abdomen\] Vs \[Day 36 100mg SUBLOCADE injection in the abdomen\]
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 Up to 112 days [16 weeks] Cmin for Cohort 7 \[Day 64 600mg INDV-6001 injection in the abdomen\] Vs \[Day 36 100mg SUBLOCADE injection in the abdomen\]
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 Up to 112 days [16 weeks] Ctrough for Cohort 7 \[Day 64 600mg INDV-6001 injection in the abdomen\] Vs \[Day 36 100mg SUBLOCADE injection in the abdomen\]
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 Up to 112 days [16 weeks] Cavg for Cohort 7 \[Day 64 600mg INDV-6001 injection in the abdomen\] Vs \[Day 36 100mg SUBLOCADE injection in the abdomen\]
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 Up to 112 days [16 weeks] % fluctuation for Cohort 7 \[Day 64 600mg INDV-6001 injection in the abdomen\] Vs \[Day 36 100mg SUBLOCADE injection in the abdomen\]
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 Up to 56 days [8 weeks] Ctrough for Cohort 4 \[Day 92 250mg INDV-6001 injection in the abdomen\] Vs Cohort 4a \[Day 120 100mg SUBLOCADE injection in the abdomen\]
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 Up to 56 days [8 weeks] Cavg for Cohort 4 \[Day 92 250mg INDV-6001 injection in the abdomen\] Vs Cohort 4a \[Day 120 100mg SUBLOCADE injection in the abdomen\]
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 Up to 56 days [8 weeks] % fluctuation for Cohort 4 \[Day 92 250mg INDV-6001 injection in the abdomen\] Vs Cohort 4a \[Day 120 100mg SUBLOCADE injection in the abdomen\]
Assessment of the safety and tolerability of INDV-6001 injection Up to 260 days 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
Trial Locations
- Locations (11)
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Innovative Clinical Research, Inc.
🇺🇸Miami Lakes, Florida, United States
Chicago Clinical Research Institute Inc.
🇺🇸Chicago, Illinois, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Hassman Research Institute (Cenexel HRI - Marlton)
🇺🇸Marlton, New Jersey, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Midwest Clinical Research
🇺🇸Dayton, Ohio, United States
Insite Clinical Research, LLC
🇺🇸Desoto, Texas, United States
Memorial Hermann Village
🇺🇸Houston, Texas, United States
Pillar Clinical Research
🇺🇸Richardson, Texas, United States
Progressive Clinical Research
🇺🇸Bountiful, Utah, United States