Taste-masking Study for Tricaprilin in Sensory Panelists

Phase 1

Completed

• Conditions: Taste Profile Assessments
• Interventions: Drug: Tricaprilin

• Registration Number: NCT03628352
• Lead Sponsor: Cerecin

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-08
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-14
• Study Start: 2018-09-10
• Primary Completion: 2019-08-22
• Study Completion: 2019-08-22
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Taste as assessed by trained sensory panelists	1 day	single dose (swish and expectorate)
Texture as assessed by trained sensory panelists	1 day	single dose (swish and expectorate)
Smell as assessed by trained sensory panelists	1 day
Palatability as assessed by trained sensory panelists	1 day	single dose (swish and expectorate)

Trial Locations

Locations (1)

Senopsys, Inc.; 🇺🇸 Woburn, Massachusetts, United States