Safety of Three Formulations of Ketasyn Administered for 14 Days in Healthy Elderly - Full Text View

Purpose

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	Intervention	Phase
Alzheimer's Disease	Other: Ketasyn	Phase 1


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Genetic and Rare Diseases Information Center resources: Alzheimer Disease Familial

U.S. FDA Resources

Further study details as provided by Accera, Inc.:

Primary Outcome Measures:

Plasma peak concentration levels and AUC [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence and severity of adverse events [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

plasma beta-hydroxybutyrate


Estimated Enrollment:	60
Study Start Date:	April 2008
Study Completion Date:	August 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	55 Years to 85 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660088

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

No publications provided


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
Study First Received:	April 11, 2008
Last Updated:	October 7, 2008
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Alzheimer Disease Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Dementia	Mental Disorders Nervous System Diseases Neurodegenerative Diseases Tauopathies

ClinicalTrials.gov processed this record on March 01, 2015