Using Bitter Taste Receptor Blockers to Improve the Palatability of Pediatric Medicines

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMonell Chemical Senses Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Between the ages of 18 and 60;

Generally healthy by self-report;

All races/ethnicities, both men and women;

Able to provide informed consent;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Flavor additives

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: There are no study arms as typically defined in a clinical trialOther 1 intervention

Trial outcomes

Primary outcomes

1

Ratings of flavor intensity

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)

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Monell Chemical Senses Center

Lead sponsor

NIAID, Division of AIDS (contract funder)

Collaborator

Advanced Biosciences Laboratories (ABL; primary contract holder)

Collaborator