CompletedPhase 1

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

United States26 participantsStarted 2019-03-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Must have the ability to understand and must personally sign a written informed consent form, which must be obtained prior to initiation of study procedures.
✓. Must be between 18 and 65 years of age, inclusive.
✓. Must have discontinued use of nicotine and nicotine containing products including vaping or juuling from 90 days prior to study drug dosing and throughout the study duration.
✓. Must be willing to abstain from any food or beverages containing alcohol 72 hours prior to first dose and through follow-up visit.
✓. Must be willing to abstain from cannabis 72 hours prior to first dose and through follow-up visit.
✓. Must be willing to abstain from caffeine (including tea, coffee, chocolate) or grapefruit, Seville orange juice or other methyl xanthine containing foods (e.g. theophylline, theobromine, tea leaves, yerba mate, kola nuts and guarana berries) 72 hours prior to the first dose and through follow- up visit.
✓. Must have a body mass index (BMI) from 19 to 30 kg/m\^2 (inclusive) at screening.
✓. Must be human immunodeficiency virus type 1 (HIV-1) antibody negative at screening.

Exclusion criteria

What they're measuring

Pharmacokinetics - Time to Maximum Concentration of Midazolam Alone

Timeframe: Day 1

Pharmacokinetics - Time to Maximum Concentration of 1-hydroxymidazolam Alone

Timeframe: Day 1

Pharmacokinetics - Maximum Total Plasma Concentration of Midazolam Alone

Timeframe: Day 1

Pharmacokinetics - Maximum Total Plasma Concentration of 1-hydroxymidazolam Alone

Timeframe: Day 1

Pharmacokinetics - Plasma Exposure of Midazolam Alone

Timeframe: Day 1

Pharmacokinetics - Plasma Exposure of 1-hydroxymidazolam Alone

Timeframe: Day 1

Pharmacokinetics - Elimination of Midazolam Alone

Timeframe: Day 1

Pharmacokinetics - Elimination of 1-hydroxymidazolam Alone

Timeframe: Day 1

Trial details

NCT IDNCT03831971

SponsorNational Institutes of Health Clinical Center (CC)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2019-08-09

Results submitted2020-06-29

View on ClinicalTrials.gov More Opiod Use Disorder trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Must have the ability to understand and must personally sign a written informed consent form, which must be obtained prior to initiation of study procedures.
✓. Must be between 18 and 65 years of age, inclusive.
✓. Must have discontinued use of nicotine and nicotine containing products including vaping or juuling from 90 days prior to study drug dosing and throughout the study duration.
✓. Must be willing to abstain from any food or beverages containing alcohol 72 hours prior to first dose and through follow-up visit.
✓. Must be willing to abstain from cannabis 72 hours prior to first dose and through follow-up visit.
✓. Must be willing to abstain from caffeine (including tea, coffee, chocolate) or grapefruit, Seville orange juice or other methyl xanthine containing foods (e.g. theophylline, theobromine, tea leaves, yerba mate, kola nuts and guarana berries) 72 hours prior to the first dose and through follow- up visit.
✓. Must have a body mass index (BMI) from 19 to 30 kg/m\^2 (inclusive) at screening.
✓. Must be human immunodeficiency virus type 1 (HIV-1) antibody negative at screening.

Exclusion criteria

What they're measuring

Pharmacokinetics - Time to Maximum Concentration of Midazolam Alone

Timeframe: Day 1

Pharmacokinetics - Time to Maximum Concentration of 1-hydroxymidazolam Alone

Timeframe: Day 1

Pharmacokinetics - Maximum Total Plasma Concentration of Midazolam Alone

Timeframe: Day 1

Pharmacokinetics - Maximum Total Plasma Concentration of 1-hydroxymidazolam Alone

Timeframe: Day 1

Pharmacokinetics - Plasma Exposure of Midazolam Alone

Timeframe: Day 1

Pharmacokinetics - Plasma Exposure of 1-hydroxymidazolam Alone

Timeframe: Day 1

Pharmacokinetics - Elimination of Midazolam Alone

Timeframe: Day 1

Pharmacokinetics - Elimination of 1-hydroxymidazolam Alone

Timeframe: Day 1