SEARCH PK Healthy Volunteer Study

Study Name

The Influence of ANS-6637 on Midazolam Pharmacokinetics in Healthy Volunteers (SEARCH PK)

Study Number

19-CC-0052

Goal of Study

Opioids are medications that are used to control pain, but are often misused. Misuse of opioids can lead to illness and early death. When people use opioids, they experience an increase in dopamine in the brain which is called "dopamine surge". The "dopamine surge" makes people feel good and often causes people to crave drugs and continue to seek them out.

ANS-6637 is an investigational drug that is being studied in this clinical trial. It is a class of drug called an aldehyde dehydrogenase 2 (ALDH – 2) inhibitor that may lower the dopamine surge in the brain and stop opioid craving. This drug has been tested in a few humans and was generally well tolerated, although some people did feel ill or have side effects. In this study, ANS-6637 will be given with midazolam, an FDA approved drug used to treat anxiety. In this study, we want to learn if ANS-6637 affects the levels of midazolam in the body. This will also help us understand if there are drug interactions between ANS-6637 and other medications which are metabolized in the same way as midazolam. This clinical trial will also study the safety and tolerability of taking ANS-6637 alone and also with midazolam.

We will recruit up to 12 participants.  Volunteers will be compensated.

Eligibility Criteria

  • You are 18-65 years old, in good general health with no active medical conditions
  • You are available to spend 9 days as an inpatient at the NIH
  • You do not take any medications, including hormonal birth control
  • You have a Body Mass Index (BMI) between 19 and 30
  • You have not used any products containing nicotine (including vaping) for the past 90 days
  • You agree not to use any products containing nicotine for entire study duration (about 15 days total)
  • You agree not to consume any caffeine (coffee, tea, chocolate) or drink grapefruit juice for at least 72 hours before start of study
  • You agree not to consume any caffeine for entire study duration (about 15 days total)
  • You agree not to consume any alcohol for at least 72 hours before start of study
  • You agree not to consume any alcohol for entire study duration (about 15 days total)
  • You agree to an HIV test at screening
  • You agree to a urine drug and alcohol test at screening
  • If female, you are not pregnant, breast feeding, or planning to become pregnant in the near future
Content last reviewed on February 4, 2019