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INDV-2000 BID + Midazolam for Healthy Subjects

Phase 1

Waitlist Available

Led By Danielle Armas, MD

Research Sponsored by Indivior Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 and day 15 at predose and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose

Awards & highlights

Study Summary

This trial looks at how a drug called INDV-2000 may affect how our bodies process other medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 and day 15 at predose and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 and day 15 at predose and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 15 at predose and 10, 20, 30, 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 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

Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinity (AUC0-∞) of Midazolam and 1-hydroxymidazolam

Area Under the Plasma Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam and 1-hydroxymidazolam

Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidazolam

Secondary outcome measures

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Trial Design

1Treatment groups

Experimental Treatment

Group I: INDV-2000 BID + MidazolamExperimental Treatment2 Interventions

Participants will receive a single oral dose of 5 mg midazolam on Day 1. Participants will receive 400 mg INDV-2000 twice a day (BID) from Days 2 to 15. On Day 15 participants will also receive a single oral dose of 5 mg midazolam co-administered with the INDV-2000 morning dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INDV-2000

2020

Completed Phase 1

~160

Midazolam

2018

Completed Phase 4

~1910

Do I qualify?Apply below to find out

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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

10,643 Total Patients Enrolled

Danielle Armas, MDPrincipal InvestigatorCelerion

13 Previous Clinical Trials

5,156 Total Patients Enrolled

Frequently Asked Questions

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

Are participants aged 80 or younger admissible for this trial?

"The age range for this clinical trial is 18 to 55. Separately, there are 51 trials dedicated to people younger than the lower cutoff and 354 focusing on those aged 65 or above."

Answered by AI

Has the INDV-2000 BID + Midazolam combination been sanctioned by the FDA?

"The safety of INDV-2000 BID + Midazolam was calculated to be a 1 on our internal scale, as the drug is still in Phase 1 and there are only minimal data points available that attest to its efficacy and security."

Answered by AI

Are enrollment opportunities currently available for those wishing to take part in the research?

"As per information shared on clinicaltrials.gov, recruitment for this trial is not currently active. In fact, the study was initially published on March 15th 2023 and last edited on January 12th 2023. However, there are 809 alternate trials that can accept participants right now."

Answered by AI

To whom is enrollment available for this research?

"This clinical trial seeks 20 individuals with healthy characteristics aged between 18 and 55. Prospective patients must meet certain criteria, including a body mass index of 18 to 32 kg/m^2 (inclusive), non-smoking status for at least 3 months prior to the first dosing, no uterus or history of permanent cessation of ovarian function due surgical removal or failure, as well as agreement by male participants to follow contraception guidelines outlined in the protocol. Most notably though, all candidates should be willing and able sign an informed consent form before enrolling in this research project."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Potential CYP3A4 Induction by INDV-2000 in Healthy Adults

2023. "Study of Potential CYP3A4 Induction by INDV-2000 in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05694533.