- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03063645
Study to Compare the Pharmacokinetics of AC 1202 and Two Doses of AC-SD-01 on Ketone Body Production
June 26, 2017 updated by: Cerecin
A Phase 1, Pilot, Single-Dose, 3-Way Crossover Study to Compare the Pharmacokinetics of AC 1202 and Two Doses of AC-SD-01 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-1202 and 2 doses of AC-SD-01.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
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
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68502
- 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
19 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy, adult, male 19-55 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.
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: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group ABC
AC-1202, AC-SD-01 (50g), AC-SD-01 (75g)
|
60 g AC-1202 mixed in 240 mL of water at Hour 0 Day 1
50 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1
75 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1
|
EXPERIMENTAL: Group BCA
AC-SD-01 (50g), AC-SD-01 (75g), AC-1202
|
60 g AC-1202 mixed in 240 mL of water at Hour 0 Day 1
50 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1
75 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1
|
EXPERIMENTAL: Group CAB
AC-SD-01 (75g), AC-1202, AC-SD-01 (50g)
|
60 g AC-1202 mixed in 240 mL of water at Hour 0 Day 1
50 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1
75 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total ketones AUC0-t
Time Frame: 0-24 hrs
|
The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method.
|
0-24 hrs
|
total ketones AUC0-inf
Time Frame: 0-24 hrs
|
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.
|
0-24 hrs
|
total ketones AUC%extap
Time Frame: 0-24 hrs
|
Percent of AUC0-inf extrapolated, represented as (1 - AUC0-t/AUC0-inf)*100
|
0-24 hrs
|
total ketones Cmax
Time Frame: 0-24 hrs
|
Maximum observed concentration
|
0-24 hrs
|
total ketones Kel
Time Frame: 0-24 hrs
|
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)
|
0-24 hrs
|
total ketones T 1/2
Time Frame: 0-24 hrs
|
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
|
0-24 hrs
|
total ketones Tmax
Time Frame: 0-24 hrs
|
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
|
0-24 hrs
|
β hydroxybutyrate AUC0-t
Time Frame: 0-24 hrs
|
The area under the concentration-time curve, from time 0 to the last observed non-zero concentration, as calculated by the linear trapezoidal method.
|
0-24 hrs
|
β hydroxybutyrate AUC0-inf
Time Frame: 0-24 hrs
|
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.
|
0-24 hrs
|
β hydroxybutyrate AUC%extap
Time Frame: 0-24 hrs
|
Percent of AUC0-inf extrapolated, represented as (1 AUC0t/ AUC0inf)* 100
|
0-24 hrs
|
β hydroxybutyrate Cmax
Time Frame: 0-24 hrs
|
Maximum observed concentration
|
0-24 hrs
|
β hydroxybutyrate Kel
Time Frame: 0-24 hrs
|
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)
|
0-24 hrs
|
β hydroxybutyrate T 1/2
Time Frame: 0-24 hrs
|
Apparent first-order terminal elimination half-life will be calculated as 0.693/Kel
|
0-24 hrs
|
β hydroxybutyrate Tmax
Time Frame: 0-24 hrs
|
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
|
0-24 hrs
|
estimate of acetoacetate AUC0-t
Time Frame: 0-24 hrs
|
Difference between total ketones AUC0-t and total β hydroxybutyrate AUC0-t
|
0-24 hrs
|
estimate of acetoacetate AUC0-inf
Time Frame: 0-24 hrs
|
Difference between total ketones AUC0-inf and total β hydroxybutyrate AUC0-inf
|
0-24 hrs
|
estimate of acetoacetate AUC%extap
Time Frame: 0-24 hrs
|
Difference between total ketones AUC%extap and total β hydroxybutyrate AUC%extap
|
0-24 hrs
|
estimate of acetoacetate Cmax
Time Frame: 0-24 hrs
|
Difference between total ketones Cmax and total β hydroxybutyrate Cmax
|
0-24 hrs
|
estimate of acetoacetate Kel
Time Frame: 0-24 hrs
|
Difference between total ketones Kel and total β hydroxybutyrate Kel
|
0-24 hrs
|
estimate of acetoacetate T 1/2
Time Frame: 0-24 hrs
|
Difference between total ketones T 1/2 and total β hydroxybutyrate T 1/2
|
0-24 hrs
|
estimate of acetoacetate Tmax
Time Frame: 0-24 hrs
|
Difference between total ketones Tmax and total β hydroxybutyrate Tmax
|
0-24 hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
March 11, 2017
Primary Completion (ACTUAL)
April 7, 2017
Study Completion (ACTUAL)
May 5, 2017
Study Registration Dates
First Submitted
February 21, 2017
First Submitted That Met QC Criteria
February 23, 2017
First Posted (ACTUAL)
February 24, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 27, 2017
Last Update Submitted That Met QC Criteria
June 26, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- AC-17-014_BE
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.
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