Using Bitter Taste Receptor Blockers to Improve the Palatability of Pediatric Medicines
NCT06929455 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-04-16
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.
Conditions
- Healthy Adults
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.
Sponsors & Collaborators
-
NIAID, Division of AIDS (contract funder)
collaborator UNKNOWN -
Advanced Biosciences Laboratories (ABL; primary contract holder)
collaborator UNKNOWN -
Monell Chemical Senses Center
lead OTHER
Principal Investigators
-
Paul M Wise, Ph.D. · Monell Chemical Senses Center
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-18
- Primary Completion
- 2026-11-01
- Completion
- 2026-11-01
Countries
- United States
Study Locations
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