Taste-masking Study for Tricaprilin in Sensory Panelists

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-10

Study Completion Date

2019-08-22

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.

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Detailed Description

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Conditions

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Taste Profile Assessments

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Tricaprilin

Approximately 5 mL liquid of tricaprilin using various flavoring agents (swish and expectorate) up to 20 times. Dose will not be ingested.

Group Type EXPERIMENTAL

Tricaprilin

Intervention Type DRUG

Tricaprilin with flavoring agents added

Interventions

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Tricaprilin

Tricaprilin with flavoring agents added

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. 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.
3. The sensory panelist is qualified based on training and experience.
4. The panelist is able to perform the required procedures according to the specified methodology
5. The panelist has provided full written consent to participate in the study.

Exclusion Criteria

1. 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.
2. The sensory panelist has a known sensitivity to medium-chain triglycerides (MCTs) or any of the excipients used in study formulations.
3. The sensory panelist has a known history of kidney disease, inflammatory bowel disease, or Bradycardia. .
4. If female, the sensory panelist is pregnant, nursing, planning to become pregnant during the study.
5. Panelist must not have any planned hospitalizations or in-patient surgical procedures that are scheduled to take place during the study.

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes