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Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder
Phase 1
Waitlist Available
Led By Martin Kankam
Research Sponsored by Indivior Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1 and 7 for part i and days 1, 7, and 28 for part ii, predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Summary
This trial tests the safety of a new drug, INDV-2000, in healthy volunteers and people with opioid use disorder. The goal is to see if the drug is safe when taken multiple times, both alone and with SUBOXONE.
Eligible Conditions
- Healthy Subjects
- Opioid Use Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1 and 7 for part i and days 1, 7, and 28 for part ii, predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 and 7 for part i and days 1, 7, and 28 for part ii, predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Part I and Part II: Area Under the Plasma Concentration-time Curve (AUC0-τ) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Part I and Part II: Maximum Plasma Concentration (Cmax) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Part I and Part II: Time to Maximum Plasma Concentration (Tmax) of INDV-2000 Following Dosing on Days 1 and 7 for Part I and Days 1, 7, and 28 for Part II
Side effects data
From 2021 Phase 1 trial • 73 Patients • NCT0441355217%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part I: INDV-2000 360 mg
Part I: INDV-2000 5 mg
Part I: INDV-2000 20 mg
Part I: INDV-2000 120 mg
Part I: INDV-2000 50 mg
Part I: INDV-2000 180 mg
Part I: Pooled Placebo
Part II Period 1: INDV-2000 360 mg Fasted
Part I: INDV-2000 720 mg
Part II Period 2: INDV-2000 360 mg Fed
Part I: INDV-2000 1 mg
Trial Design
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Part III INDV-2000 400 mg BID + SUBOXONE SL FilmExperimental Treatment2 Interventions
Participants with opioid use disorder will receive SUBOXONE sublingual (SL) film for 6 days during the run-in period. Participants will then receive SUBOXONE SL film alone for 2 days, then SUBOXONE SL film and INDV-2000 for 7 days followed by INDV-2000 dosing alone for 4 days.
Group II: Part II Cohort 2 INDV-2000 400 mg BIDExperimental Treatment1 Intervention
Healthy volunteers will receive INDV-2000 400 mg twice daily for 28 days.
Group III: Part II Cohort 1 INDV-2000 200 mg BIDExperimental Treatment1 Intervention
Healthy volunteers will receive INDV-2000 200 mg twice daily for 28 days.
Group IV: Part I Cohort 2 INDV-2000 100 mg BIDExperimental Treatment1 Intervention
Healthy volunteers will receive INDV-2000 100 mg twice daily for 7 days.
Group V: Part I Cohort 1 INDV-2000 100 mg QDExperimental Treatment1 Intervention
Healthy volunteers will receive INDV-2000 100 mg once daily for 7 days.
Group VI: Part I Cohort 1 PlaceboPlacebo Group1 Intervention
Healthy volunteers will receive placebo once daily for 7 days.
Group VII: Part I Cohort 2 PlaceboPlacebo Group1 Intervention
Healthy volunteers will receive placebo twice daily for 7 days.
Group VIII: Part II Cohort 1 PlaceboPlacebo Group1 Intervention
Healthy volunteers will receive placebo twice daily for 28 days.
Group IX: Part II Cohort 2 PlaceboPlacebo Group1 Intervention
Healthy volunteers will receive placebo twice daily for 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SUBOXONE® sublingual film
2022
Completed Phase 1
~70
INDV-2000
2020
Completed Phase 1
~160
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,594 Previous Clinical Trials
3,328,672 Total Patients Enrolled
Indivior Inc.Lead Sponsor
55 Previous Clinical Trials
11,292 Total Patients Enrolled
Martin KankamPrincipal Investigatoraltasciences
1 Previous Clinical Trials
73 Total Patients Enrolled
Ellen RemenchikPrincipal InvestigatorWorldwide Clinical Trails