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

NCT ID: NCT06929455

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-18
• Study Completion Date: 2026-11-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Flavor additives

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NIAID, Division of AIDS (contract funder)

UNKNOWN

Sponsor Role: collaborator

Advanced Biosciences Laboratories (ABL; primary contract holder)

UNKNOWN

Sponsor Role: collaborator

Monell Chemical Senses Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul M Wise, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Monell Chemical Senses Center

Locations

Monell Chemical Senses Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paul M Wise, Ph.D.

Role: CONTACT

TasteOfMedicinesStudy@monell.org

267-519-4799

Facility Contacts

Paul M Wise, Ph.D.

Role: primary

pwise@monell.org

267-519-0400

Paul AS Breslin, Ph.D.

Role: backup

breslin@monell.org

267-519-4780

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

AI 75N93023D00001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

75N93024F00002

Identifier Type: -

Identifier Source: org_study_id