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

NCT05694533 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-28

Study results available
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Summary

The purpose of this study is to investigate the potential for cytochrome P450 (CYP) 3A4 induction after dosing with INDV-2000 via use of midazolam as a probe.

Conditions

  • Healthy

Interventions

DRUG

INDV-2000

Capsules administered orally twice a day

DRUG

Midazolam

Midazolam syrup administered orally on Days 1 and 15

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Indivior Inc.

    lead INDUSTRY

Principal Investigators

  • Danielle Armas, MD · Celerion

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-16
Primary Completion
2023-04-06
Completion
2023-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05694533 on ClinicalTrials.gov