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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adults
• Intervention / Treatment: Other: Flavor additives

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul M Wise, Ph.D.; Phone Number: 267-519-4799; Email: TasteOfMedicinesStudy@monell.org

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Monell Chemical Senses Center
      • Contact: Paul M Wise, Ph.D.; Phone Number: 267-519-0400; Email: pwise@monell.org
      • Contact: Paul AS Breslin, Ph.D.; Phone Number: 267-519-4780; Email: breslin@monell.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Through study completion, between about 2 months and 3 years, depending on the number of API-flavor combinations individual participants choose to evaluate

Collaborators and Investigators

• Sponsor: Monell Chemical Senses Center
• Collaborators: NIAID, Division of AIDS (contract funder); Advanced Biosciences Laboratories (ABL; primary contract holder)
• Investigators: Principal Investigator: Paul M Wise, Ph.D., Monell Chemical Senses Center

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 75N93024F00002; AI 75N93023D00001 (Other Grant/Funding Number: NIH NIAID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared with qualified researchers upon request, and may be made available in managed repositories as allowed by funder and journal policy.
• IPD Sharing Time Frame: De-identified data will be made available upon publication of results, as consistent with applicable Journal policies. Once available, data will be available indefinitely. Note, however, that individual participants will have the option to opt out of the data-base upon request to the study PI. Once such a request is received, data for the individual participant concerned will no longer be available.
• IPD Sharing Access Criteria: Data will be made available to qualified researchers by the study PI upon request (after publication). If data are placed in managed repositories (e.g., NIH-run managed repository), qualifications will be determined by the managers of the repository

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes