Taste Profile Assessments
Conditions
Brief summary
This is an open-label multiple-dose study of the taste profile of tricaprilin formulated as a powder for reconstitution.
Interventions
DRUGTricaprilin
Tricaprilin with flavoring agents added
Sponsors
Cerecin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Taste as assessed by trained sensory panelists | 1 day | single dose (swish and expectorate) |
| Smell as assessed by trained sensory panelists | 1 day | — |
| Texture as assessed by trained sensory panelists | 1 day | single dose (swish and expectorate) |
| Palatability as assessed by trained sensory panelists | 1 day | single dose (swish and expectorate) |
Countries
United States
Outcome results
None listed