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OpenTrials
Completed

NCT Number: NCT03628352

Taste-masking Study for Tricaprilin in Sensory Panelists

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

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Key information

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Senopsys, Inc.

Woburn, Massachusetts, 01801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Tricaprilin

Drug

Tricaprilin with flavoring agents added

Primary outcomes

  1. Taste as assessed by trained sensory panelists

    Time frame: 1 day

    single dose (swish and expectorate)

  2. Smell as assessed by trained sensory panelists

    Time frame: 1 day

  3. Texture as assessed by trained sensory panelists

    Time frame: 1 day

    single dose (swish and expectorate)

  4. Palatability as assessed by trained sensory panelists

    Time frame: 1 day

    single dose (swish and expectorate)

Sponsors and collaborators

Lead sponsor

Cerecin

Industry

Registry information

Official study title

An Open-Label Taste Assessment of Tricaprilin Formulated as a Powder for Reconstitution in Healthy Panelists

Acronym: TMS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2018
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.