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INDV-2000 First in Human

NCT04413552 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2024-05-16

Study results available
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Summary

This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable safety evaluation, a food-interaction, single-dose study under fed and fasted conditions will be conducted.

Conditions

  • Opioid Dependence

Interventions

DRUG

INDV-2000

INDV-2000 will be administered as either powder in solution or powder in capsule, depending on dose administered.

DRUG

Placebo

Placebo will be administered as either powder in solution or powder in capsule, depending on dose administered.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Indivior Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Kankam · Altasciences Company Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-07-06
Primary Completion
2021-04-13
Completion
2021-04-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04413552 on ClinicalTrials.gov