INDV-2000 for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Healthy Subjects (HS)+3 More
INDV-2000 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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 (HS)
  • Opioid Use Disorder (OUD)

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Day 1 and Day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

Day 7
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
Day 18
Part III: Number of Participants with Adverse Events
Day 35
Part I and Part II: Number of Participants with Adverse Events

Trial Safety

Side Effects for

Part I: INDV-2000 120 mg
17%Presyncope
17%Blood creatine phosphokinase increased
This histogram enumerates side effects from a completed 2021 Phase 1 trial (NCT04413552) in the Part I: INDV-2000 120 mg ARM group. Side effects include: Presyncope with 17%, Blood creatine phosphokinase increased with 17%.

Trial Design

5 Treatment Groups

Part I: INDV-2000
1 of 5
Part III: INDV-2000 + SUBOXONE
1 of 5
Part II: INDV-2000
1 of 5
Part I: Placebo
1 of 5
Part II: Placebo
1 of 5
Experimental Treatment
Non-Treatment Group

64 Total Participants · 5 Treatment Groups

Primary Treatment: INDV-2000 · Has Placebo Group · Phase 1

Part I: INDV-2000
Drug
Experimental Group · 1 Intervention: INDV-2000 · Intervention Types: Drug
Part III: INDV-2000 + SUBOXONEExperimental Group · 2 Interventions: INDV-2000, SUBOXONE® sublingual film · Intervention Types: Drug, Drug
Part II: INDV-2000
Drug
Experimental Group · 1 Intervention: INDV-2000 · Intervention Types: Drug
Part I: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Part II: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INDV-2000
2020
Completed Phase 1
~80

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 and day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose

Who is running the clinical trial?

Indivior Inc.Lead Sponsor
48 Previous Clinical Trials
9,234 Total Patients Enrolled
2 Trials studying Healthy Subjects (HS)
62 Patients Enrolled for Healthy Subjects (HS)
Martin KankamPrincipal Investigatoraltasciences
1 Previous Clinical Trials
73 Total Patients Enrolled
Ellen RemenchikPrincipal InvestigatorWorldwide Clinical Trails

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Use of combined hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal.
You are a sexually active person who has not engaged in sexual intercourse with another person for at least one year.
You have had a vasectomy or bilateral tubal ligation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: October 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Missouri100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Altasciences100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%