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NCT03831971 · ClinicalTrials.gov registry record · Phase 1
The Influence of ANS-6637 on Midazolam Pharmacokinetics in Healthy Volunteers
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03831971: Completed Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT03831971 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03831971, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study 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.
Primary Outcome
Time to maximum plasma concentration (tmax). The summary PK results were informed by a continuous measurement at the following serial blood collection time points: 0 (pre-dose), then 0.5, 1, 2, 3, 4, 6, 8, 12, 22, and 24 hours postdose.
Interventions
- DRUG ANS-6637
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2019-12-30 |
| Phase | Phase 1 |
What the finished NCT03831971 record still lists
NCT03831971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which ANS-6637 is the first listed.
NCT03831971 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03831971 about?
NCT03831971 is a clinical study titled "The Influence of ANS-6637 on Midazolam Pharmacokinetics in Healthy Volunteers". 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 lowe...
What is the current status of trial NCT03831971?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2019-03-01. Estimated completion is 2019-12-30.
What interventions are being tested in trial NCT03831971?
The interventions under investigation include: ANS-6637 (DRUG).
Who is sponsoring clinical trial NCT03831971?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03831971's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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