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

NCT06929455 | Recruiting

• 2 other identifiers: 75N93024F00002AI 75N93023D00001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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)

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

Study Arms (1)

There are no study arms as typically defined in a clinical trial

OTHER

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

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.

There are no study arms as typically defined in a clinical trial

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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). -

You may not qualify if:

• 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

Sponsors & Collaborators

• Monell Chemical Senses Center: lead
• NIAID, Division of AIDS (contract funder): collaborator
• Advanced Biosciences Laboratories (ABL; primary contract holder): collaborator

Study Sites (1)

Monell Chemical Senses Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Interventions

Flavoring Agents

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Paul M Wise, Ph.D.

  Monell Chemical Senses Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul M Wise, Ph.D.

CONTACT

267-519-4799; TasteOfMedicinesStudy@monell.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Samples for tasting will be presented with numeric identification codes (no verbal descriptors) and be presented in random order within a tasting session.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are no formal arms. Some samples will contain pharmaceutical ingredients without added flavors (control), and some samples will contain both pharmaceutical ingredients and flavor additives (experimental condition to determine if added flavors ingredients improve the flavor of the samples).

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 16, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• 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.
• 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

Locations

US (1)