Safety of Three Formulations of Ketasyn Administered for 14 Days in Healthy Elderly
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ClinicalTrials.gov Identifier: NCT00660088 |
Recruitment Status
:
Completed
First Posted
: April 17, 2008
Last Update Posted
: October 8, 2008
|
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Condition or disease | Intervention/treatment |
---|---|
Alzheimer's Disease | Other: Ketasyn |
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 |

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
|
- Plasma peak concentration levels and AUC [ Time Frame: two weeks ]
- Incidence and severity of adverse events [ Time Frame: 3 weeks ]
Biospecimen Retention: Samples Without DNA

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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 |
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

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
United States, Florida | |
Meridien Research Center | |
St. Petersburg, Florida, United States, 33709 |
Study Director: | Lauren Costantini, PhD | Accera, Inc. |
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 Key Record Dates |
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 |