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CompletedNCT03628352TMSUpdated Nov 6, 2019

Taste-masking Study for Tricaprilin in Sensory Panelists

A Phase 1 interventional study of Tricaprilin in Taste Profile Assessments, sponsored by Cerecin. Completed at 1 site in United States. Open to participants aged 25 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-06.

Sponsored by Cerecin · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Aug 2019, 7 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
25 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Taste Profile Assessments
03

In context

Lead sponsor

Cerecin is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 80 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Tricaprilin

    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

  • DrugTricaprilin

    Tricaprilin with flavoring agents added

06

What researchers measure

Primary outcomes

  1. Taste as assessed by trained sensory panelists

    single dose (swish and expectorate)

    Time frame: 1 day

  2. Smell as assessed by trained sensory panelists

    Time frame: 1 day

  3. Texture as assessed by trained sensory panelists

    single dose (swish and expectorate)

    Time frame: 1 day

  4. Palatability as assessed by trained sensory panelists

    single dose (swish and expectorate)

    Time frame: 1 day

07

Study locations

1 site
  • Senopsys, Inc.
    Woburn, Massachusetts 01801, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03628352
Lead sponsor
Cerecin
Responsible party
Sponsor
First posted
Aug 14, 2018
Start date
Sep 10, 2018
Primary completion
Aug 22, 2019
Completion
Aug 22, 2019
Last update
Nov 6, 2019

Study contacts

Carol McKenna
principal investigator · Senopsys

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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