Overview

This trial is active, not recruiting.

Condition healthy
Treatments caprylic triglyceride oil, ac-1202, axona, ac-1204
Phase phase 1
Sponsor Accera, Inc.
Collaborator Celerion
Start date July 2016
End date August 2016
Trial size 20 participants
Trial identifier NCT02833012, AC-16-012_BE

Summary

To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of acetoacetate) levels after single dose administration of caprylic triglyceride (CT) oil, AC-1202, AC-1204, and Axona®.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model crossover assignment
Masking open label
Arm
(Experimental)
Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204
caprylic triglyceride oil
10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1
ac-1202
60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1
axona
40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1
ac-1204
40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1
(Experimental)
Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204
caprylic triglyceride oil
10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1
ac-1202
60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1
axona
40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1
ac-1204
40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1
(Experimental)
Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204
caprylic triglyceride oil
10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1
ac-1202
60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1
axona
40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1
ac-1204
40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1
(Experimental)
Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204
caprylic triglyceride oil
10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1
ac-1202
60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1
axona
40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1
ac-1204
40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1

Primary Outcomes

Measure
total ketones AUC0-t
time frame: 0-24 hours
total ketones AUC0-inf
time frame: 0-24 hours
total ketones AUC%extap
time frame: 0-24 hours
total ketones Cmax
time frame: 0-24 hours
total ketones Kel
time frame: 0-24 hours
total ketones T 1/2
time frame: 0-24 hours
total ketones Tmax
time frame: 0-24 hours
β hydroxybutyrate AUC0-t
time frame: 0-24 hours
β hydroxybutyrate AUC0-inf
time frame: 0-24 hours
β hydroxybutyrate AUC%extap
time frame: 0-24 hours
β hydroxybutyrate Cmax
time frame: 0-24 hours
β hydroxybutyrate Kel
time frame: 0-24 hours
β hydroxybutyrate T 1/2
time frame: 0-24 hours
β hydroxybutyrate Tmax
time frame: 0-24 hours
estimate of acetoacetate AUC0-t
time frame: 0-24 hours
estimate of acetoacetate AUC0-inf
time frame: 0-24 hours
estimate of acetoacetate AUC%extap
time frame: 0-24 hours
estimate of acetoacetate Cmax
time frame: 0-24 hours
estimate of acetoacetate Kel
time frame: 0-24 hours
estimate of acetoacetate T 1/2
time frame: 0-24 hours
estimate of acetoacetate Tmax
time frame: 0-24 hours

Eligibility Criteria

Male participants from 18 years up to 55 years old.

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. 3. Body mass index (BMI) ≥ 20.0 and ≤ 30.0 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. 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). 6. 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 2 years prior to Day -1 of Period 1. 5. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, milk, palm or coconut oil, or soy. 6. History or presence of diverticular disease, ulcers, inflammatory bowel disease or recurrent diarrhea or gout. 7. Positive urine drug or alcohol results at screening or check in. 8. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV). 9. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening. 10. Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening. 11. QTcF interval is >460 msec or has ECG findings deemed abnormal with clinical significance by the PI or designee at screening. 12. Estimated creatinine clearance ≤80 mL/min at screening. 13. Unable to refrain from or anticipates the use of any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to Day -1 of Period 1 and throughout the study. Acetaminophen (up to 2 g per 24 hour period) may be permitted during the study. 14. Has been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 28 days prior to Day -1 of Period 1 and throughout the study. 15. Is lactose intolerant. 16. Is unable to complete the meal prior to Day -1 of Period 1. 17. Subject consumed grapefruit or Seville oranges within 14 days prior to Day -1 of Period 1. 18. Donation of blood or significant blood loss within 56 days prior to Day -1 of Period 1. 19. Plasma donation within 7 days prior to Day -1 of Period 1. 20. Participation in another clinical study within 28 days prior to Day -1 of Period 1. The 28 day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day -1 of Period 1 of the current study.

Additional Information

Official title A Phase 1, Pilot, Single-Dose, 4-Way Crossover Study to Compare the Pharmacokinetics of Caprylic Triglyceride Oil, AC-1202, AC-1204, and Axona on Ketone Body Production
Principal investigator Colleen Hunsaker, D.O.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Accera, Inc..