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INDV-2000 for Healthy Subjects

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 day 1 and day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Awards & highlights

Study Summary

This trial will assess the safety and tolerability of a new drug, INDV-2000, in healthy volunteers and in an opioid use disorder treatment seeking population.

Eligible Conditions
  • Healthy Subjects
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part I and Part II: Number of Participants with Adverse Events
Part III: Number of Participants with Adverse Events
Secondary outcome measures
Part I and Part II: Area under the plasma concentration-time curve (AUC0-24) of INDV-2000 following dosing on Days 1 and 7
Part I and Part II: Maximum plasma concentration (Cmax) of INDV-2000 following dosing on Days 1 and 7
Part I and Part II: Time to maximum plasma concentration (Tmax) of INDV-2000 following dosing on Days 1 and 7

Side effects data

From 2021 Phase 1 trial • 73 Patients • NCT04413552
17%
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

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part III: INDV-2000 + SUBOXONEExperimental 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: INDV-2000Experimental Treatment1 Intervention
Healthy volunteers will receive INDV-2000 twice daily for 28 days.
Group III: Part I: INDV-2000Experimental Treatment1 Intervention
Healthy volunteers will receive INDV-2000 once daily or twice daily for 7 days.
Group IV: Part II: PlaceboPlacebo Group1 Intervention
Healthy volunteers will receive placebo twice daily for 28 days.
Group V: Part I: PlaceboPlacebo Group1 Intervention
Healthy volunteers will receive placebo either once daily or twice daily for 7 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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Indivior Inc.Lead Sponsor
53 Previous Clinical Trials
10,599 Total Patients Enrolled
Martin KankamPrincipal Investigatoraltasciences
1 Previous Clinical Trials
73 Total Patients Enrolled
Ellen RemenchikPrincipal InvestigatorWorldwide Clinical Trails

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for those wishing to join this clinical trial?

"Current data on clinicaltrials.gov implies that this investigation is actively enlisting individuals into their research. The project was made public on August 17th 2022 and the most recent information update occurred September 26th of the same year."

Answered by AI

What is the current enrollment capacity of this research project?

"Indeed, clinicaltrials.gov states that this medical trial is currently open for recruitment as of September 26th 2022. It was initially posted on August 17th and requires 64 individuals to be enrolled from 2 different sites."

Answered by AI

How is INDV-2000 typically employed to help patients?

"INDV-2000 is commonly employed to treat opioid addiction, in addition to other ailments such as pruritus, pain and septic shock."

Answered by AI

Has INDV-2000 achieved regulatory approval from the FDA?

"Due to limited data regarding its efficacy and safety, INDV-2000 has been assigned a rating of 1 on our scale."

Answered by AI

What criteria must be met for an individual to qualify as a participant in this medical study?

"This clinical trial is looking for 64 human subjects between the ages of 18-65 who are in good health. Candidates must also meet additional criteria such as having a BMI within 18-32 kg/m^2, using contraceptives like condoms with spermicidal gel or female caps, and males/females aged 18 to 55 years old (with a minimum weight of 50kg at screening)."

Answered by AI

Are there any age restrictions for participation in this scientific experiment?

"This medical experiment is only open to participants aged 18-65. For those who do not meet the age criteria, there are 143 studies available for minors and 815 studies that seniors can join."

Answered by AI

Could you elaborate on the other trials that have used INDV-2000 in their research?

"Presently, 55 clinical trials investigating the effects of INDV-2000 are live with 13 in Phase 3. While White River Junction is a major research site for INDV-2000, there are over 200 other locations hosting related studies."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Kansas
How old are they?
18 - 65
What site did they apply to?
Altasciences
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder
2022. "Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04976855.
~24 spots leftby Apr 2025
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