100 Participants Needed

Bitter Taste Receptor Blockers for Improving Pediatric Medicine Palatability

PM
Overseen ByPaul M Wise, Ph.D.
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Monell Chemical Senses Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

Yes, participants must not have used any prescription or over-the-counter medications daily or within the last four weeks, except for birth control.

What data supports the effectiveness of flavor additives in improving the palatability of pediatric medicines?

Research shows that adding sodium salts to bitter-tasting medicines can make them taste better and be more acceptable to children, which helps them take their medicine as needed. This suggests that using flavor additives could be an effective way to improve the taste of pediatric medicines and encourage children to take them.12345

Is it safe to use bitter taste receptor blockers in humans?

Bitter taste receptor blockers like sodium acetate, sodium gluconate, and adenosine 5'monophosphate have been shown to have a good safety profile and are generally regarded as safe for use in humans.12678

How does this drug improve the taste of pediatric medicine?

This drug uses bitter taste receptor blockers, which are compounds that interact with the molecular pathway of bitterness to reduce the unpleasant taste of medicines. This approach is unique because it directly targets the taste receptors, making it potentially more effective for improving the palatability of bitter medications, especially for children.12679

What is the purpose of this trial?

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.

Research Team

PM

Paul M Wise, Ph.D.

Principal Investigator

Monell Chemical Senses Center

Eligibility Criteria

This trial is for healthy adults aged 18 to 60 who are interested in helping improve the taste of pediatric medicines. Participants will be tasting, but not swallowing, various liquid or gel samples containing active ingredients used in medications like those for HIV and tuberculosis.

Inclusion Criteria

Able to provide informed consent
My gender or race does not exclude me from this trial.
I can go to Monell for multiple sensory tests.
See 2 more

Exclusion Criteria

I have diabetes or another metabolic disorder.
Pregnant, nursing, or plans to become pregnant
Dentures or other major dental implants
See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tasting Sessions

Participants taste samples containing active pharmaceutical ingredients with and without experimental flavor ingredients and judge how the samples taste.

2 months to 3 years
Many repeated visits to the Monell Center, each lasting 1-2 hours

Follow-up

Participants are monitored for any adverse reactions or changes in taste perception after tasting sessions

4 weeks

Treatment Details

Interventions

  • Flavor additives
Trial Overview The study is testing flavor additives that could block bitter taste receptors, aiming to make liquid drugs more palatable for children. Adults will sample these potential additives with different medications during visits to the Monell Center.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: There are no study arms as typically defined in a clinical trialExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Monell Chemical Senses Center

Lead Sponsor

Trials
22
Recruited
2,200+

NIAID, Division of AIDS (contract funder)

Collaborator

Advanced Biosciences Laboratories (ABL; primary contract holder)

Collaborator

References

Age-related differences in bitter taste and efficacy of bitter blockers. [2021]
Modification of bitter taste in children. [2018]
Evaluation of patient-reported outcome measurements as a reliable tool to measure acceptability of the taste of paediatric medicines in an inpatient paediatric population. [2019]
Taste assessment for paediatric drug Development: A comparison of bitterness taste aversion in children versus Naïve and expert young adult assessors. [2023]
Pharmacogenetics of taste: turning bitter pills sweet? [2013]
Bitter-blockers as a taste masking strategy: A systematic review towards their utility in pharmaceuticals. [2021]
Taste masking technologies in oral pharmaceuticals: recent developments and approaches. [2022]
A new strategy for taste masking of azithromycin antibiotic: development, characterization, and evaluation of azithromycin titanium nanohybrid for masking of bitter taste using physisorption and panel testing studies. [2022]
Formulation and development of taste masked fast-disintegrating tablets (FDTs) of Chlorpheniramine maleate using ion-exchange resins. [2013]
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