Safety of Three Formulations of Ketasyn Administered for 14 Days in Healthy Elderly

Study Overview
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Brief Summary
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AC-1202 (Ketasyn) is a nutritional beverage currently being studied in neurodegenerative conditions including Alzheimer's disease. The current study is a randomized, open-label trial to compare the safety, tolerability, and PK profiles of 3 formulations of Ketasyn administered on a daily basis for 14 days, with and without a 7-day titration period, in normal, healthy elderly volunteers.

Detailed Description
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Sixty healthy, elderly volunteers between the ages of 55 and 85 will be enrolled at one of four clinical sites in the Tampa/St. Petersburg area. Subjects with a history of GI inflammatory conditions (e.g., IBS or diverticulitis) or other clinically significant abnormalities will be excluded from enrollment. Subjects will be randomized to one of two dosing regimens (with or without a 7-day titration period) and to one of three formulations of Ketasyn containing the identical amount of active ingredient, but different amounts of proteins and carbohydrates. Subjects assigned to Group 1 will receive 10 grams active ingredient daily on Days 1-7, followed by a daily dose of 20 grams active ingredient on Days 8-14. Subjects assigned to Group 2 will receive 20 grams active ingredient on Days 1-14. All subjects will have clinic visits on Day 1 and 14; subjects assigned to Group 1 will also have a clinic visit on Day 8. Subjects will fast prior to each clinic visit and have vital signs and routine lab tests performed prior to dosing. A standard breakfast will be served along with the study product, following which blood samples will be collected for product concentration levels.

Official Title
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Tolerability, Safety, And Pharmacokinetics Of Three Formulations Of Oral Ketasyn™ (Ac-1202) Administered For Fourteen Days, With Or Without Titration, In Healthy Elderly Volunteers

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Other: Ketasyn


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No clinically significant abnormal findings on physical exam, vital signs, medical history, ECG, or laboratory results Exclusion Criteria: Type 1 or uncontrolled Type 2 diabetes History of or current inflammation of GI system, e.g. IBS, diverticular disease, gastric or duodenal ulcers, severe GERD requiring daily medication History (within past 60 days) of infections Clinically significant renal, hepatic, or hematologic abnormalities

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>10 gram x 7 days, then 20 gram x 7 days active ingredient of original formulation | Other: Ketasyn<br>* 10g for 7 days, 20g for 7 or 14 days<br>|
| 2<br>20 grams x 14 days active ingredient of original formulation | Other: Ketasyn<br>* 10g for 7 days, 20g for 7 or 14 days<br>|
| 3<br>10 grams x 7 days; then 20 grams x 7 days of low protein formulation | Other: Ketasyn<br>* 10g for 7 days, 20g for 7 or 14 days<br>|
| 4<br>20 grams x 14 days of low protein formulation | Other: Ketasyn<br>* 10g for 7 days, 20g for 7 or 14 days<br>|
| 5<br>10 grams x 7 days; then 20 grams x 7 days of high protein formulation | Other: Ketasyn<br>* 10g for 7 days, 20g for 7 or 14 days<br>|
| 6<br>20 grams x 14 days of high protein formulation | Other: Ketasyn<br>* 10g for 7 days, 20g for 7 or 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma peak concentration levels and AUC |  | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events |  | 3 weeks |