Healthy Adults
Conditions
Brief summary
Many people, particularly small children, must take drugs in liquid form because they cannot swallow pills or capsules. The bad taste of some liquid drugs can keep patients from taking drugs they need for their health. Our main goal in this research study is find ingredients that might make drugs taste better. Participants in this research study will be healthy adults between the ages of 18 and 60 years old. Participants will taste samples (liquids or gels) containing active pharmaceutical ingredients (substances in medications that produce desired health effects). After tasting each sample participants will spit out the sample and rinse with water (no samples will be swallowed). Active pharmaceutical ingredients of current interest are: 1) tenofovir alafenamide, used to treat HIV infection and hepatitis B, 2) rifampicin, used to treat tuberculosis, 3) rifapentine, used to treat tuberculosis, and 4) levofloxacin, used to treat various bacterial infections). Other active pharmaceutical ingredients may be added as the study goes forward. Participants will be instructed to taste samples both with and without experimental flavor ingredients added and judge how the samples taste. People who volunteer for the study will be instructed to complete many repeated visits to the Monell Center (University City area of Philadelphia) for tasting sessions. Tasting visits will last between 1 and 2 hours.
Interventions
OTHERFlavor additives
Various flavors will be added to API samples. The particular APIs and flavor additives to be studied will be determined in part by on-going in work using in vitro taste models (cell systems expressing taste receptor proteins), so there is no full prespecified list.
Sponsors
NIAID, Division of AIDS (contract funder)
Advanced Biosciences Laboratories (ABL; primary contract holder)
Monell Chemical Senses Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Samples for tasting will be presented with numeric identification codes (no verbal descriptors) and be presented in random order within a tasting session.
Intervention model description
There are no formal arms. Some samples will contain pharmaceutical ingredients without added flavors (control), and some samples will contain both pharmaceutical ingredients and flavor additives (experimental condition to determine if added flavors ingredients improve the flavor of the samples).
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 18 and 60; * Generally healthy by self-report; * All races/ethnicities, both men and women; * Able to provide informed consent; * Able to attend repeated visits to Monell for sensory testing; * Willing to follow instructions (e.g., refrain from eating or drinking for at least 1 hour before sessions, willing to remain on site for one hour after tasting an API that the participant has never tasted before). -
Exclusion criteria
* Under 18 or over 60; * Pregnant, nursing, or plans to become pregnant; * Unable to provide consent (including limited ability to understand written and spoken English); * Tobacco, vape, marijuana, or tetrahydrocannabinol cartridge users. We will accept people who have used tobacco or marijuana products on occasion, but not regular users; * Known drug or food allergies of any kind; * Diabetes or other metabolic disorder; * Liver issues of any kind, including viral hepatitis; * Kidney issues of any kind; * Other chronic illness, including cardiovascular, neurological, immune disorders, or any other serious acute or chronic condition * Dentures or other major dental implants; * Condition affecting the oral cavity, including dry mouth, burning mouth syndrome, active sores or blisters, geographic tongue, or other disorders * Current infection or cold, flu, or infection with SARS-CoV-2 within the last four weeks; * Unable to taste or smell * Daily use, or use within the last four weeks, of either prescription or over-the-counter medications (except for birth control) * History of tuberculosis (including latent tuberculosis), positive skin or other tuberculosis test at any time in the past, birth in or residence in a country with high tuberculosis rates, known contact with someone who is tuberculosis positive * HIV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratings of flavor intensity | Through study completion, between about 2 months and 3 years, depending on the number of API-flavor combinations individual participants choose to evaluate | Ratings of oral sensation (e.g., bitterness, sourness, astringency, etc.) made using the general Labeled Magnitude Scale. Values range from 0 (no sensation) to 100 (strongest imaginable sensation) |
Countries
United States
Contacts
Primary ContactPaul M Wise, Ph.D.
Outcome results
None listed