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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 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 26 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03831971
The ClinicalTrials.gov registry entry for NCT03831971 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ANS-6637 is the first listed.
NCT03831971 reports 0 study locations.
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.
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