Clinical trial NCT00660088: Safety of Three Formulations of Ketasyn Administered for 14 Days in Healthy Elderly
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Lead sponsor: Cerecin
Sponsor class: INDUSTRY
First posted: 2008-04-17
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy elderly male and female subjects 55 - 85 years of age

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.

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 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

Primary outcomes:
measure: Plasma peak concentration levels and AUC
timeFrame: two weeks
Secondary outcomes:
measure: Incidence and severity of adverse events
timeFrame: 3 weeks
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: Meridien Research Center
state: Florida
Study officials:
affiliation: Cerecin
name: Lauren Costantini, PhD
role: STUDY_DIRECTOR
References: