NCT06929455 · Monell Chemical Senses Center
Using Bitter Taste Receptor Blockers to Improve the Palatability of Pediatric Medicines
What this study is about
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.
View original scientific description
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
OTHER
Flavor 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.
Primary outcome measures
Ratings of flavor intensity
Time frame: 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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Philadelphia, Pennsylvania
Collaborators
NIAID, Division of AIDS (contract funder), Advanced Biosciences Laboratories (ABL; primary contract holder)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2025 · Source of record for eligibility and locations