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The Influence of ANS-6637 on Midazolam Pharmacokinetics in Healthy Volunteers

NCT03831971 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-08-03

Study results available
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Summary

Background:

Opioids are medicines that control pain. But they are often misused, which can lead to illness and death. Opioids increase dopamine to the brain, which makes people feel good and often causes them to crave drugs, leading to misuse and addiction. An investigational drug ANS-6637 may lower the dopamine surge and stop opioid craving. Midazolam is a drug approved for anxiety. Researchers want to give the two drugs together and see if ANS-6637 affects midazolam levels, to help understand how ANS-6637 is used in the body.

Objective:

To study the safety, tolerability, and effects of ANS-6637 taken with and without midazolam.

Eligibility:

Healthy adults 18 65 years old

Design:

Participants will be screened with a medical history, physical exam, and blood and heart tests. Participants who can get pregnant will have a pregnancy test.

Participants must agree to use 2 types of birth control during the study, if applicable.

Participants will stay at the clinic for 10 days. Meals will be provided. Participants will not be allowed to:

Leave NIH campus

Eat or drink anything with caffeine, alcohol, or certain juices

Use any nicotine or related products (including vaping)

Use any medicines (including herbal)

During the clinic stay, participants will:

Fast overnight several times

Have blood drawn most days. Twice, a small tube will be inserted in an arm vein for frequent blood samples.

Repeat screening tests and answer questions about their mood several times

Get midazolam syrup in water on 1 day

Take 6 ANS-6637 tablets by mouth on 5 days

Take both study drugs on 1 day

A few days later, participants will have a follow-up visit to repeat screening tests and answer questions about their mood.

Conditions

  • Opiod Use Disorder

Interventions

DRUG

ANS-6637

Subjects will receive (1) midazolam 5 mg po single dose on Day 1 followed by (2) Drug free period on Day 2 followed by (3) ANS-6637 600 mg po daily (Days 3-7) to reach steady state followed by (4) ANS-6637 600 mg po single dose + midazolam 5mg po single dose on Day 8

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Henry Masur, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-08-09
Completion
2019-12-30
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 NCT03831971 on ClinicalTrials.gov