Taste-masking Study for Tricaprilin in Sensory Panelists

Study Overview
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Brief Summary
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This is an open-label multiple-dose study of the taste profile of tricaprilin formulated as a powder for reconstitution.

Official Title
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An Open-Label Taste Assessment of Tricaprilin Formulated as a Powder for Reconstitution in Healthy Panelists

Conditions
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Taste Profile Assessments

Intervention / Treatment
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* Drug: Tricaprilin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The healthy male or female sensory panelist is between 25 and 80 years of age (inclusive) who volunteers for study participation and is able to read, understand, and sign and date a written informed consent form (ICF) before study participation. The panelist is male, or is a non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol, or is a female of non-childbearing potential. The sensory panelist is qualified based on training and experience. The panelist is able to perform the required procedures according to the specified methodology The panelist has provided full written consent to participate in the study. Exclusion Criteria: The sensory panelist has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the sensory panelist. The sensory panelist has a known sensitivity to medium-chain triglycerides (MCTs) or any of the excipients used in study formulations. The sensory panelist has a known history of kidney disease, inflammatory bowel disease, or Bradycardia. . If female, the sensory panelist is pregnant, nursing, planning to become pregnant during the study. Panelist must not have any planned hospitalizations or in-patient surgical procedures that are scheduled to take place during the study.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tricaprilin<br>Approximately 5 mL liquid of tricaprilin using various flavoring agents (swish and expectorate) up to 20 times. Dose will not be ingested. | Drug: Tricaprilin<br>* Tricaprilin with flavoring agents added<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste as assessed by trained sensory panelists | single dose (swish and expectorate) | 1 day | 
| Smell as assessed by trained sensory panelists |  | 1 day | 
| Texture as assessed by trained sensory panelists | single dose (swish and expectorate) | 1 day | 
| Palatability as assessed by trained sensory panelists | single dose (swish and expectorate) | 1 day |