Evaluation of PK of Caprylic Triglyceride Oil, AC-1202, AC-1204, and Axona on Ketone Body Production

NCT ID: NCT02833012

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-12-31

Brief 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®.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1

Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204

Group Type: EXPERIMENTAL

Caprylic Triglyceride Oil

Intervention Type: DRUG

10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1

AC-1202

Intervention Type: DRUG

60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1

Axona

Intervention Type: DRUG

40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1

AC-1204

Intervention Type: DRUG

40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1

Group 2

Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204

Group Type: EXPERIMENTAL

Caprylic Triglyceride Oil

Intervention Type: DRUG

10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1

AC-1202

Intervention Type: DRUG

60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1

Axona

Intervention Type: DRUG

40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1

AC-1204

Intervention Type: DRUG

40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1

Group 3

Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204

Group Type: EXPERIMENTAL

Caprylic Triglyceride Oil

Intervention Type: DRUG

10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1

AC-1202

Intervention Type: DRUG

60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1

Axona

Intervention Type: DRUG

40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1

AC-1204

Intervention Type: DRUG

40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1

Group 4

Caprylic Triglyceride Oil, AC-1202, Axona, AC-1204

Group Type: EXPERIMENTAL

Caprylic Triglyceride Oil

Intervention Type: DRUG

10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1

AC-1202

Intervention Type: DRUG

60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1

Axona

Intervention Type: DRUG

40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1

AC-1204

Intervention Type: DRUG

40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1

Interventions

Caprylic Triglyceride Oil

10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1

Intervention Type: DRUG

AC-1202

60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1

Intervention Type: DRUG

Axona

40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1

Intervention Type: DRUG

AC-1204

40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Celerion

INDUSTRY

Sponsor Role: collaborator

Cerecin

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colleen Hunsaker, D.O.

Role: PRINCIPAL_INVESTIGATOR

Celerion

Locations

Celerion, Inc

Tempe, Arizona, United States

Countries

United States

Other Identifiers

AC-16-012_BE

Identifier Type: -

Identifier Source: org_study_id