Safety of Three Formulations of Ketasyn Administered for 14 Days in Healthy Elderly
This study has been completed.
Sponsor:
Accera, Inc.
ClinicalTrials.gov Identifier:
NCT00660088
First Posted: April 17, 2008
Last Update Posted: October 8, 2008
Information provided by:
Accera, Inc.
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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
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 ]
Secondary Outcome Measures:
- Incidence and severity of adverse events [ Time Frame: 3 weeks ]
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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 55 Years to 85 Years (Adult, Senior) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
| 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 Submitted: | April 11, 2008 |
| 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 |