Taste-masking Study for Tricaprilin in Sensory Panelists

NCT03628352 | Completed Phase 1 FDA Drug

• 1 other identifier: AC-18-019_TM
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Taste Profile Assessments

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Tricaprilin

EXPERIMENTAL

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

Drug: Tricaprilin

Interventions

Tricaprilin DRUG

Tricaprilin with flavoring agents added

Tricaprilin

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cerecin: lead

Study Sites (1)

Senopsys, Inc.

Woburn, Massachusetts, 01801, United States

Location

MeSH Terms

Interventions

tricaprylin

Study Officials

• Carol McKenna

  Senopsys

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 14, 2018
• Study Start: September 10, 2018
• Primary Completion: August 22, 2019
• Study Completion: August 22, 2019
• Last Updated: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)