TMS: Taste-masking Study for Tricaprilin in Sensory Panelists

• Sponsor: Cerecin (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03628352
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Actual Duration (Months): 11.4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Taste Profile Assessments	Drug: Tricaprilin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: An Open-Label Taste Assessment of Tricaprilin Formulated as a Powder for Reconstitution in Healthy Panelists
• Actual Study Start Date: Sep 10, 2018
• Actual Primary Completion Date: Aug 22, 2019
• Actual Study Completion Date: Aug 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
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; Tricaprilin with flavoring agents added

Outcome Measures

Primary Outcome Measures

1. Taste as assessed by trained sensory panelists [1 day]

   single dose (swish and expectorate)

2. Smell as assessed by trained sensory panelists [1 day]

3. Texture as assessed by trained sensory panelists [1 day]

   single dose (swish and expectorate)

4. Palatability as assessed by trained sensory panelists [1 day]

   single dose (swish and expectorate)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Senopsys, Inc.	Woburn	Massachusetts	United States	01801

Sponsors and Collaborators

• Cerecin

Investigators

• Principal Investigator: Carol McKenna, Senopsys

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cerecin
• ClinicalTrials.gov Identifier: NCT03628352
• Other Study ID Numbers: AC-18-019_TM
• First Posted: Aug 14, 2018
• Last Update Posted: Nov 6, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 6, 2019