Viewing Study NCT00660088



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Last Modification Date: 2024-10-26 @ 9:48 AM
Study NCT ID: NCT00660088
Status: COMPLETED
Last Update Posted: 2008-10-08
First Post: 2008-04-11

Brief Title: Safety of Three Formulations of Ketasyn Administered for 14 Days in Healthy Elderly
Sponsor: Cerecin
Organization: Cerecin

Study Overview

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
Status: COMPLETED
Status Verified Date: 2008-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: AC-1202 Ketasyn is a nutritional beverage currently being studied in neurodegenerative conditions including Alzheimers 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: Sixty healthy elderly volunteers between the ages of 55 and 85 will be enrolled at one of four clinical sites in the TampaSt Petersburg area Subjects with a history of GI inflammatory conditions eg 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None