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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Monell Chemical Senses Center
Study ID
NCT06929455
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Adults

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Flavor additives — OTHER
    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.

Study Details

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.

Key Dates

Start date
Mar 18, 2025
Status verified
Apr 2025
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: There are no study arms as typically defined in a clinical trial
    Various APIs will be presented with and without flavor additives. The list of APIs and additives will be developed as the study progresses, informed by ongoing work using in vitro taste assays. There are no formal, pre-specified study arms as typically defined in a clinical trial.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Monell Chemical Senses CenterPhiladelphiaPennsylvania19104
Paul M Wise, Ph.D.
[email protected]
267-519-0400
Paul AS Breslin, Ph.D.
[email protected]
267-519-4780

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