Status:
COMPLETED
A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin and Matching Placebo in Healthy Subjects
Lead Sponsor:
Cerecin
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the PK, safety, and tolerability of a new liquid formulation of tricaprilin.
Eligibility Criteria
Inclusion
- Main
- Healthy males and non-pregnant, non-lactating healthy females aged 18 to 55 years inclusive at time of signing informed consent with a body weight ≥55 kg.
- Body mass index (BMI) 18.0 to 32.0 kg/m2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.
- Main
Exclusion
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Subjects with a history of fainting, dizziness, bradycardia or hypotension as considered clinically significant by the investigator
- Subject has a medical condition that may adversely affect taste or smell activity
Key Trial Info
Start Date :
July 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05408780
Start Date
July 14 2022
End Date
October 24 2022
Last Update
October 17 2023
Active Locations (1)
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1
Quotient Sciences Miami
Miami, Florida, United States, 33126