Sensory Evaluation of the Taste of Pediatric Medicines
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 2/27/2019 |
| Start Date: | September 1, 2018 |
| End Date: | April 1, 2023 |
| Contact: | Julie A. Mennella, PhD |
| Email: | mennella@monell.org |
| Phone: | 2675194880 |
Taste of Medicines for Children: Genetic Variation and Medical Adherence (Aim 1)
The investigators will conduct a systematic study of the sensory perception of a diverse set
of commonly used pediatric liquid medications and excipients in tandem with an equally
complete genetic analysis of the adult sensory panelists to investigate the relationship
between genetic variation and individual differences in the perceived flavor (taste, smell,
irritation) of pediatric medicines. The flavor of each medicine and excipient will be
measured individually using both cognitively demanding methods unsuitable for young children
and simpler measures validated for use by children. Salivary DNA samples will be collected to
carry out genome wide association study (GWAS).
of commonly used pediatric liquid medications and excipients in tandem with an equally
complete genetic analysis of the adult sensory panelists to investigate the relationship
between genetic variation and individual differences in the perceived flavor (taste, smell,
irritation) of pediatric medicines. The flavor of each medicine and excipient will be
measured individually using both cognitively demanding methods unsuitable for young children
and simpler measures validated for use by children. Salivary DNA samples will be collected to
carry out genome wide association study (GWAS).
This is a single-site, cross-sectional, repeated measures study of healthy adult panelists
which will investigate individual differences in the taste of a diverse set of commonly used
pediatric liquid medications (e.g., clindamycin, prednisone, dexamethasone, mercaptopurine,
ibuprofen, lopinavir/ritonavir, propylthiouracil) and excipients (e.g., sucrose, citric acid,
bitter agents, salt, menthol and other odors) in tandem with genetic analysis. Because the
medication given to pediatric patients is the whole liquid formulation (API + excipients),
the investigators' approach will be to have panelists taste (without swallowing) what
patients taste. Using validated psychophysical tools such as the general labelled magnitude
scale (gLMS), the hedonic gLMS, and the hedonic 5-face scale, adults panelists will rate the
intensity of the basic tastes, overall intensity, irritation, or palatability (hedonics) of a
variety of pediatric drugs (with and without noseclips), along with generally recognized as
safe (GRAS) taste and odor stimuli commonly used in basic research and/or as excipients in
many liquid formulations These data will establish whether the palatability and flavor of
each medicine varies among adult panelists. From these data, the investigators will determine
a) whether the dislike of one medicine by a panelist predicts their dislike of another
medicine in the same class or medicines with the same excipients; b) whether variation in the
flavor and palatability ratings of each medicine relates to variation in genetic
polymorphisms, as determined from the GWAS; and c) whether the panelists' palatability
ratings of each medicine, as assessed by the simpler hedonic 5-face scale, is significantly
related to hedonic gLMS ratings.
which will investigate individual differences in the taste of a diverse set of commonly used
pediatric liquid medications (e.g., clindamycin, prednisone, dexamethasone, mercaptopurine,
ibuprofen, lopinavir/ritonavir, propylthiouracil) and excipients (e.g., sucrose, citric acid,
bitter agents, salt, menthol and other odors) in tandem with genetic analysis. Because the
medication given to pediatric patients is the whole liquid formulation (API + excipients),
the investigators' approach will be to have panelists taste (without swallowing) what
patients taste. Using validated psychophysical tools such as the general labelled magnitude
scale (gLMS), the hedonic gLMS, and the hedonic 5-face scale, adults panelists will rate the
intensity of the basic tastes, overall intensity, irritation, or palatability (hedonics) of a
variety of pediatric drugs (with and without noseclips), along with generally recognized as
safe (GRAS) taste and odor stimuli commonly used in basic research and/or as excipients in
many liquid formulations These data will establish whether the palatability and flavor of
each medicine varies among adult panelists. From these data, the investigators will determine
a) whether the dislike of one medicine by a panelist predicts their dislike of another
medicine in the same class or medicines with the same excipients; b) whether variation in the
flavor and palatability ratings of each medicine relates to variation in genetic
polymorphisms, as determined from the GWAS; and c) whether the panelists' palatability
ratings of each medicine, as assessed by the simpler hedonic 5-face scale, is significantly
related to hedonic gLMS ratings.
Inclusion Criteria:
- Men and women who are between the ages of 18 and 55 years
Exclusion Criteria include the following:
- For all female participants, a urine pregnancy test will be done on each testing day.
Only those with a negative pregnancy test will be allowed to participate in taste
testing.
- Smokers will be excluded since it alters flavor perception.
- Potential subjects will be excluded if they are on drugs with potential serious
adverse effects that are mediated through CYP450 3A4 since ritonavir is a potent
inhibitor of CYP450 3A4 and could lead to elevated levels of the prohibited drugs if
swallowed. The prohibited drugs include the following:
- Alfuzosin (Uroxatral; alpha-1-adrenoreceptor antagonist)
- Astemizole (Hismanal; antihistamine)
- Bepridil (Vascor; calcium channel blocker)
- Cerivastatin (Baycol; statin)
- Cisapride (Propulsid; GI motility agent)
- Dronedarone (multaq; anti-arrhythmic)
- Ergotamine (Cafergot, Ergot derivatives)
- Flecainide (Tabocor; anti-arrhythmic)
- Lovastatin (Altoprev; HMG-CoA Reductase Inhibitor)
- Lurasidone (Latuda; antipsychotic)
- Midazolam (Versed; sedative/hypnotic)
- Pimozide (Orap; antipsychotic)
- Ranolazine (Ranexa; anti-anginal)
- Simvastatin (Zocor; statin)
- Terfenadine (Seldane; antihistamine)
- Tinidazole (Tindamax; anti-parasitic)
- Trazodone (Desyrel; antidepressant/sedative)
- Triazolam (Halcion; sedative)
- Warfarin (Coumadin; blood thinner)
- Potential subjects will be excluded if they have had current (within the last 24
hours) use of sildenafil (Viagra), tadalafil (Cialis), and verdenafil (Levitra) are
also exclusion criteria. These drugs can be used as needed for erectile dysfunction.
They are also used as a daily treatment for pulmonary arterial hypertension. With
CYP450 3A4 blockade and current use, hypotension, syncope, and prolonged erection are
possible.
- Potential subjects will be excluded if they have known allergies or hypersensitivity
reactions to lopinavir, ritonavir, clindamycin, prednisone, dexamethasone, ibuprofen,
6-mercaptopurine, propylthiouracil, or any of the excipients in the liquid
formulations to be tested.
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