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Completed

NCT Number: NCT02959710

Evaluation of PK of AC-1204 Mixed in Water, AC-1202 Mixed in Water, and AC-1202 Mixed in Ensure® on Ketone Body Production

To compare serum ketone body (i.e., total ketones, β hydroxybutyrate, and estimate of acetoacetate) levels after single dose administration of AC-1204 mixed in water, AC-1202 mixed in water and AC-1202 mixed in Ensure®.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Body mass index (BMI) ≥ 20.0 and ≤ 30.0 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.
  • 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.

Exclusion criteria

  • 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 2 years 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 diverticular disease, ulcers, inflammatory bowel disease or recurrent diarrhea or gout.
  • Positive urine drug or alcohol results at screening or check in.
  • 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.
  • 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 hour period) 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.
  • Is lactose intolerant.
  • Is unable to complete the meal prior to Hour 0 on Day -1 of Period 1 and prior to dosing on Day 1 of Period 1.
  • Subject consumed grapefruit or Seville oranges within 14 days prior to Day -1 of Period 1.
  • Donation of blood or significant blood loss within 56 days prior to Day -1 of Period 1.
  • Plasma donation within 7 days prior to Day -1 of Period 1.
  • 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.

Treatment and study plan

AC-1204 mixed in water

Drug

40 g AC-1204 (shaken in 240 mL of water) at Hour 0 on Day 1

AC-1202 mixed in water

Drug

60 g AC-1202 (shaken in 240 mL of water) at Hour 0 on Day 1

AC-1202 mixed in Ensure®

Drug

60 g AC-1202 (shaken in approximately 8 oz [237 mL of Ensure® Original] at Hour 0 on Day 1)

Primary outcomes

  1. total ketones AUC0-t

    Time frame: 0-24 hours

    The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method.

  2. total ketones AUC0-inf

    Time frame: 0-24 hours

    The area under the concentration-time curve from time 0 extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the ratio of the last measurable serum concentration to the elimination rate constant.

  3. total ketones AUC%extap

    Time frame: 0-24 hours

    Percent of AUC0-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100

  4. total ketones Cmax

    Time frame: 0-24 hours

    Maximum observed concentration

  5. total ketones Kel

    Time frame: 0-24 hours

    Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the serum concentration versus time curve. The parameter will be calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., there or more non-zero serum concentrations)

  6. total ketones T 1/2

    Time frame: 0-24 hours

    Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel

  7. total ketones Tmax

    Time frame: 0-24 hours

    Time to reach Cmax. If the value occurs at more than one time points, Tmax is defined as the first time point with this value

  8. β hydroxybutyrate AUC0-t

    Time frame: 0-24 hours

    The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method.

  9. β hydroxybutyrate AUC0-inf

    Time frame: 0-24 hours

    The area under the concentration time curve from time 0 extrapolated to infinity. AUC0inf is calculated as the sum of AUC0t plus the ratio of the last measurable serum concentration to the elimination rate constant.

  10. β hydroxybutyrate AUC%extap

    Time frame: 0-24 hours

    Percent of AUC0-inf extrapolated, represented as (1 AUC0t/ AUC0inf)* 100

  11. β hydroxybutyrate Cmax

    Time frame: 0-24 hours

    Maximum observed concentration

  12. β hydroxybutyrate Kel

    Time frame: 0-24 hours

    Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the serum concentration versus time curve. The parameter will be calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more nonzero serum concentrations)

  13. β hydroxybutyrate T 1/2

    Time frame: 0-24 hours

    Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel

  14. β hydroxybutyrate Tmax

    Time frame: 0-24 hours

    Time to reach Cmax. If the value occurs at more than one time point, Tmax is defined as the first time point with this value

  15. estimate of acetoacetate AUC0-t

    Time frame: 0-24 hours

    The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method.

  16. estimate of acetoacetate AUC0-inf

    Time frame: 0-24 hours

    The area under the concentration-time curve from time 0 extrapolated to infinity. AUC0-inf is calculated as the sum of AUC0-t plus the ratio of the last measurable serum concentration to the elimination rate constant.

  17. estimate of acetoacetate AUC%extap

    Time frame: 0-24 hours

    Percent of AUC0-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)* 100

  18. estimate of acetoacetate Cmax

    Time frame: 0-24 hours

    Maximum observed concentration

  19. estimate of acetoacetate Kel

    Time frame: 0-24 hours

    Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the serum concentration versus time curve. The parameter will be calculated by linear least-square regression analysis using the maximum number of points in the terminal log-linear phase (e.g., three or more non-zero concentrations)

  20. estimate of acetoacetate T 1/2

    Time frame: 0-24 hours

    Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel

  21. estimate of acetoacetate Tmax

    Time frame: 0-24 hours

    Time to reach Cmax. If the value occurs at more than one time point, Tmax is defined as the first time point with this value

Sponsors and collaborators

Lead sponsor

Cerecin

Industry

Collaborators

  • Celerion

Registry information

Official study title

A Phase 1, Pilot, Single-Dose, 3-Way Crossover Study to Compare the Pharmacokinetics of AC-1204 Mixed in Water, AC-1202 Mixed in Water, and AC-1202 Mixed in Ensure® on Ketone Body Production

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 9, 2016
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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