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

NCT03635879 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: AX-18-018_PK
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (15)

• Total ketones

  Area Under the Curve (AUC) AUC 0 - last

  1 day

• Total ketones

  AUC 0 - 4

  1 day

• Total ketones

  AUC 0 - 6

  1 day

• Total ketones

  AUC 0 - 8

  1 day

• Total ketones

  Maximum Plasma Concentration (Cmax)

  1 day

• B-hydroxybutyrate

  AUC 0 - last

  1 day

• B-hydroxybutyrate

  AUC 0 - 4

  1 day

• B-hydroxybutyrate

  AUC 0 - 6

  1 day

• B-hydroxybutyrate

  AUC 0 - 8

  1 day

• B-hydroxybutyrate

  Cmax

  1 day

• Acetoacetate

  AUC 0 - last

  1 day

• Acetoacetate

  AUC 0 - 4

  1 day

• Acetoacetate

  AUC 0 - 6

  1 day

• Acetoacetate

  AUC 0 - 8

  1 day

• Acetoacetate

  Cmax

  1 day

Study Arms (6)

MCTprocal medical food

ACTIVE COMPARATOR

Vitaflo MCTprocal, single dose (20 g MCT)

Other: MCTprocal medical food

Milk/tricaprilin oil blend

ACTIVE COMPARATOR

Lactose-free milk and tricaprilin oil, blended,single dose (20 g tricaprilin)

Other: Milk/tricaprilin oil blend

AC-1207

ACTIVE COMPARATOR

AC-1207 liquid, single dose (20 g tricaprilin)

Other: AC-1207

AC-1205

ACTIVE COMPARATOR

AC-1205 liquid, single dose (20 g tricaprilin)

Other: AC-1205

AC-1206

ACTIVE COMPARATOR

AC-1206 liquid, single dose (20 g tricaprilin)

Other: AC-1206

AC-1202

EXPERIMENTAL

AC-1206 liquid, single dose (20 g tricaprilin)

Drug: AC-1202

Interventions

MCTprocal medical food OTHER

32 g MCTprocal (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1

MCTprocal medical food

Milk/tricaprilin oil blend OTHER

154 mL of lactose-free skim milk/21 mL of tricaprilin oil blended and then mixed in 180 mL of water at Hour 0 Day 1

Milk/tricaprilin oil blend

AC-1207 OTHER

AC-1207 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1

AC-1207

AC-1205 OTHER

AC-1205 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1

AC-1205

AC-1206 OTHER

AC-1206 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1

AC-1206

AC-1202 DRUG

AC-1202 (20 g MCT) mixed in 240 mL of water at Hour 0 Day 1

AC-1202

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, adult, male 18 55 years of age, inclusive, at Screening.
• 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.
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening.
• 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.
• Hemoglobin levels ≥ the lower limit of normal at Screening and Day -1 of Period 1.
• 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).
• Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

You may not qualify if:

• 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.
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
• 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.
• History or presence of alcoholism or drug abuse within the past year prior to Day -1 of Period 1.
• History or presence of galactosemia or hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, milk, palm or coconut oil, or soy.
• History or presence of symptomatic diverticular disease, uncontrolled gastroesophageal reflux disease, ulcers, inflammatory bowel disease, irritable bowel syndrome or recurrent diarrhea, or gout.
• Positive urine drug results at Screening or Check-in.
• Positive alcohol results at Screening or Check-in. One repeat assessment is permitted.
• Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
• Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at Screening. One repeat assessment is permitted.
• Seated heart rate is lower than 40 bpm or higher than 99 bpm at Screening.
• QTcF interval is \>460 msec or subject has ECG findings deemed abnormal with clinical significance by the PI or designee at Screening.
• Estimated creatinine clearance ≤ 80 mL/min at Screening.
• 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 hours) may be permitted during the study.
• 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.

Sponsors & Collaborators

• Cerecin: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

AC-1202

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 17, 2018
• Study Start: February 13, 2019
• Primary Completion: April 16, 2019
• Study Completion: April 16, 2019
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share