Using Bitter Taste Receptor Blockers to Improve the Palatability of Pediatric Medicines: Trained Human Sensory Panels

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• 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). -

Locations
United States
Pennsylvania
Monell Chemical Senses Center
RECRUITING
Philadelphia
Contact Information
Primary
Paul M Wise, Ph.D.
TasteOfMedicinesStudy@monell.org
267-519-4799
Time Frame
Start Date: 2025-03-18
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Monell Chemical Senses Center
Collaborators: Advanced Biosciences Laboratories (ABL; primary contract holder), NIAID, Division of AIDS (contract funder)

This content was sourced from clinicaltrials.gov