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Lipid Emulsion
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
Phase 1
Waitlist Available
Research Sponsored by Cerecin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 28 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new liquid form of tricaprilin, a type of fat. The study aims to see how this liquid fat behaves in the body and if it is safe and well-tolerated. Tricaprilin is known for being quickly converted into energy by the body.
Eligible Conditions
- Alzheimer's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part A)
Incidence of Treatment Emergent Adverse Events (Part B)
Secondary study objectives
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part B)
Incidence of Treatment Emergent Adverse Events (Part A)
Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after administration of tricaprilin and placebo formulations (Part A, Part B)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part B - Titration TolerabilityExperimental Treatment1 Intervention
Subjects will be dosed BID in the morning and afternoon (approximately 5 h apart) on Days 1 to 27. Both doses of active or matching placebo IMP will be administered in the fed state either 30 min after completion of a standard-fat and calorie content breakfast or 30 min after a standardized-fat and calorie content lunch.
Participants will be randomised to either study drug or the matching placebo.
Group II: Part A - Food Effect AssessmentExperimental Treatment1 Intervention
Subjects will be randomized before administration of the first dose of active or matching placebo IMP in a 1:1:1:1 ratio to 1 of 4 treatment sequences (ABCD, BACD, ABDC, BADC) so that all subjects receive Regimens A, B, C and D across the 4 periods.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AC-OLE-01-VA
2022
Completed Phase 1
~70
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
CerecinLead Sponsor
22 Previous Clinical Trials
1,822 Total Patients Enrolled
Study DirectorStudy DirectorCerecin
1,281 Previous Clinical Trials
500,457 Total Patients Enrolled