- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04268953
Study to Compare the Pharmacokinetics of Daily Administration of Tricaprilin on Ketone Body Production
July 7, 2020 updated by: Cerecin
A Phase 1, Single-centre, Multiple-dose, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of the AC-SD-03 Formulation of Tricaprilin in Healthy Older Volunteers
This is a Phase I, single center, open label, multiple dose, pharmacokinetic (PK) study recruiting healthy older subjects.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85283
- Celerion
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy, adult, males or females, age 50 years and above, at Screening.
- Subject must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12 lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, Type 2 diabetes, etc) will be permitted to enrol.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening.
- Agrees to comply with study procedures including the confinement period of 28 days.
- Subject is able and willing to consume a prescribed full breakfast, lunch and dinner while confined in the CRU. Subject does not have specific dietary requirements (vegetarian, vegan, lactose-free, low-fat, etc.).
- Subject is not consuming a ketogenic diet (defined by consumption of < 50 gm carbohydrates per day).
- A non vasectomized male subject must agree to use a condom or abstain from sexual intercourse during the study and for 90 days following last dose of AC-SD 03. No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to Screening. A subject who has been vasectomized less than 4 months prior to Screening must follow the same restrictions as a non vasectomized male.
- Female subjects must be either surgically sterile or 2 or more years post-menopause.
- Has given voluntary, written informed consent to participate in the study.
Exclusion Criteria:
- History or presence of alcoholism or substance abuse disorder within the last year.
- Positive urine drug screen at Screening or Check-In.
- Subject is currently actively using MCTs, ketone esters, or other ketogenic products or is following a ketogenic diet.
- Clinically significant abnormal laboratory results at Screening that in the opinion of the PI preclude participating in this study
- Participation in another clinical trial within 30 days prior to Check-In.
- Subject has a known allergy to the study drug's active or inactive ingredients.
- Subject has been following a ketogenic diet (or other diet incompatible with the on-study diet), in the opinion of the investigator.
Unable to refrain from, or anticipates the use of drugs other than allowed products, including prescription and non-prescription medications, beginning 14 days prior to the first dose and throughout the study.
- Allowed medications include anti-hypertensive agents, statins, aspirin in a dose of 100 mg or less per day for prophylaxis.
- Paracetamol (acetaminophen), up to 4 g per 24 hour period, or ibuprofen (up to 1200 mg per 24-hour period) may be permitted during the study.
- Herbal remedies and vitamin supplements are permitted in usual doses (not hyper supplementation) so long as subject has been on stable amounts for at least 6 weeks.
- Agents being taken to improve memory or cognition are not allowed, whether herbal, 'natural' or pharmaceutical.
- Subject is known HIV, HBV or HCV positive, or has a positive test at Screening.
- Any other condition which, in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AC-SD-03
Study drug administered concurrently with a standard meal
|
Tricaprilin formulated as AC-SD-03 mixed in 300mL water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of multiple-dose administrations of tricaprilin formulated as AC-SD-03 administered using a titration scheme in healthy older volunteers
Time Frame: 32 days
|
TEAE incidence rate
|
32 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics (PK) parameters of Total Ketones levels after multiple dose of AC-SD-03 using AUC(0-t)
Time Frame: 28 days
|
AUC(0-t) will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate) Levels.
AUC (0-t) = Area under the concentration-time curve from 0 to last quantifiable concentration.
Summary statistics will be generated for each PK parameter.
|
28 days
|
Pharmacokinetics (PK) parameters of Total Ketones levels after multiple dose of AC-SD-03 using Cmax
Time Frame: 28 days
|
Cmax will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate) Levels.
Cmax = Cmax is maximum concentration, determined directly from individual concentration-time data.Summary statistics will be generated for each PK parameter.
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 27, 2020
Primary Completion (Actual)
March 26, 2020
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
February 12, 2020
First Submitted That Met QC Criteria
February 12, 2020
First Posted (Actual)
February 13, 2020
Study Record Updates
Last Update Posted (Actual)
July 8, 2020
Last Update Submitted That Met QC Criteria
July 7, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC-20-021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
AphiosNot yet recruitingDementia | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3
-
Capital Medical UniversityPeking University First Hospital; The First Affiliated Hospital of Anhui Medical... and other collaboratorsRecruitingAlzheimer Disease | Familial Alzheimer Disease (FAD)China
-
University of PennsylvaniaNational Institute on Aging (NIA)CompletedDementia | Alzheimer Disease, At Risk | Alzheimer Disease, Protection AgainstUnited States
-
Kyoto UniversityOsaka University; Mie University; Tokushima University; Tokyo Metropolitan Geriatric... and other collaboratorsCompletedFamilial Alzheimer Disease (FAD) | PSEN1 MutationJapan
-
University of ArizonaNational Institute on Aging (NIA); University of Southern California; Syneos... and other collaboratorsRecruitingNeurodegenerative Diseases | Alzheimer Dementia | Late Onset Alzheimer DiseaseUnited States
-
National Taiwan Normal UniversityCompletedAlzheimer Disease 2 Due to Apoe4 IsoformTaiwan
-
Northwell HealthRecruitingAlzheimer Disease | Alzheimer Disease With Delusions | Alzheimer Disease With PsychosisUnited States
-
University of Kansas Medical CenterNational Institute on Aging (NIA)CompletedHealthy Aging | Alzheimer Disease 2 Due to Apoe4 IsoformUnited States
Clinical Trials on Tricaprilin
-
CerecinCompletedTaste Profile AssessmentsUnited States
-
CerecinActive, not recruiting
-
CerecinCompletedAlzheimer DiseaseAustralia
-
CerecinCompleted
-
CerecinCompleted
-
CerecinCompletedAlzheimer DiseaseAustralia
-
CerecinWithdrawn