Taste-masking Study for Tricaprilin in Sensory Panelists (TMS)

Cerecin

Status and phase: Completed; Phase 1

Conditions: Taste Profile Assessments

Treatments: Drug: Tricaprilin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03628352

AC-18-019_TM

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

Tricaprilin

Experimental group

Description:

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

Treatment:

Drug: Tricaprilin