Status:

RECRUITING

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

Lead Sponsor:

Monell Chemical Senses Center

Collaborating Sponsors:

NIAID, Division of AIDS (contract funder)

Advanced Biosciences Laboratories (ABL; primary contract holder)

Conditions:

Healthy Adults

Eligibility:

All Genders

18-60 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 18 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06929455

Start Date

March 18 2025

End Date

November 1 2026

Last Update

April 16 2025

Active Locations (1)

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1

Monell Chemical Senses Center

Philadelphia, Pennsylvania, United States, 19104