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Medical Food Formulation Pharmacokinetic (PK) Study in Medium Chain Triglycerides | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

Medical Food Formulation Pharmacokinetic (PK) Study in Medium Chain Triglycerides

A Phase 1, Single-Center, Pilot, Single-Dose, 6-Way Crossover Study to Compare Six Formulations of Medium Chain Triglycerides on the Pharmacokinetics of Ketone Body Production

NCT03635879•Cerecin

View on ClinicalTrials.gov

Summary

This is a Phase I, open label, randomized, 6-way crossover, pilot PK study

Detailed Description

12 healthy, male subjects enrolled, subject will be randomized to receive a single dose of one of six treatment, with a 2 day washout in between each dosing period.

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy, adult, male 18 55 years of age, inclusive, at Screening.
•2. Continuous non smoker who has not used nicotine containing products for at least 3 months prior to Day -1 of Period 1 and throughout the study based on self-reporting.
•3. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening.
•4. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee. At screening, subjects must have alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ the upper limit of normal and triglyceride levels must be \< 250 mg/dL.
•5. Hemoglobin levels ≥ the lower limit of normal at Screening and Day -1 of Period 1.
•6. A non vasectomized subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to Day -1 of Period 1. A subject who has been vasectomized less than 4 months prior to Day -1 of Period 1 must follow the same restrictions as a non vasectomized male).
•7. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria

•1. Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
•2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
•3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
•4. History or presence of alcoholism or drug abuse within the past year prior to Day -1 of Period 1.
•5. History or presence of galactosemia or hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, milk, palm or coconut oil, or soy.
•6. History or presence of symptomatic diverticular disease, uncontrolled gastroesophageal reflux disease, ulcers, inflammatory bowel disease, irritable bowel syndrome or recurrent diarrhea, or gout.
•7. Positive urine drug results at Screening or Check-in.
•8. Positive alcohol results at Screening or Check-in. One repeat assessment is permitted.
•9. Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
•10. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at Screening. One repeat assessment is permitted.
+11 more criteria

Key Dates

Start Date

February 13, 2019

Primary Completion Date

April 16, 2019

Completion Date

April 16, 2019

Last Updated

September 27, 2018

Conditions

Alzheimer Disease

Interventions

MCTprocal medical food

OTHER

Milk/tricaprilin oil blend

OTHER

AC-1207

OTHER

AC-1205

OTHER

AC-1206

OTHER

AC-1202

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 27, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Medical Food Formulation Pharmacokinetic (PK) Study in Medium Chain Triglycerides

Inclusion Criteria

Exclusion Criteria

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