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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment
Alzheimer's Disease	Other: Ketasyn

Detailed Description:

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	60 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Tolerability, Safety, And Pharmacokinetics Of Three Formulations Of Oral Ketasyn™ (Ac-1202) Administered For Fourteen Days, With Or Without Titration, In Healthy Elderly Volunteers
Study Start Date :	April 2008
Actual Primary Completion Date :	June 2008
Actual Study Completion Date :	August 2008

Groups and Cohorts

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Group/Cohort	Intervention/treatment
1; 10 gram x 7 days, then 20 gram x 7 days active ingredient of original formulation	Other: Ketasyn; 10g for 7 days, 20g for 7 or 14 days
2; 20 grams x 14 days active ingredient of original formulation	Other: Ketasyn; 10g for 7 days, 20g for 7 or 14 days
3; 10 grams x 7 days; then 20 grams x 7 days of low protein formulation	Other: Ketasyn; 10g for 7 days, 20g for 7 or 14 days
4; 20 grams x 14 days of low protein formulation	Other: Ketasyn; 10g for 7 days, 20g for 7 or 14 days
5; 10 grams x 7 days; then 20 grams x 7 days of high protein formulation	Other: Ketasyn; 10g for 7 days, 20g for 7 or 14 days
6; 20 grams x 14 days of high protein formulation	Other: Ketasyn; 10g for 7 days, 20g for 7 or 14 days

Outcome Measures

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Primary Outcome Measures :

1. Plasma peak concentration levels and AUC [ Time Frame: two weeks ]

Secondary Outcome Measures :

1. Incidence and severity of adverse events [ Time Frame: 3 weeks ]

Biospecimen Retention:   Samples Without DNA

plasma beta-hydroxybutyrate

Eligibility Criteria

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Ages Eligible for Study:	55 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy elderly male and female subjects 55 - 85 years of age

Criteria

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

Contacts and Locations

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Locations

United States, Florida
Meridien Research Center
St. Petersburg, Florida, United States, 33709

Sponsors and Collaborators

Accera, Inc.

Investigators

Study Director:	Lauren Costantini, PhD	Accera, Inc.

More Information

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Responsible Party:	Lauren Costantini, PhD; Vice President Clinical Development, Accera, Inc.
ClinicalTrials.gov Identifier:	NCT00660088 History of Changes
Other Study ID Numbers:	KET-08-004
First Posted:	April 17, 2008
Last Update Posted:	October 8, 2008
Last Verified:	October 2008

Additional relevant MeSH terms:

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