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Sponsored by: |
Chiesi Pharmaceuticals Inc. |
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Information provided by: | Chiesi Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT00954252 |
The purpose of this study is to evaluate the safety and tolerability of single oral doses of CHF 5074 in young healthy male volunteers.
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Drug: CHF 5074 Drug: placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF 5074 in Healthy Young Male Subjects |
Estimated Enrollment: | 60 |
Study Start Date: | October 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Test Article: Experimental |
Drug: CHF 5074
1x, oral capsule, single dose
Drug: CHF 5074
2x, oral capsule, single dose
Drug: CHF 5074
4x, oral capsule, single dose
Drug: CHF 5074
8x, oral capsule, single dose
Drug: CHF 5074
16x, oral capsule, single dose
Drug: CHF 5074
24x, oral capsule, single dose
|
Placebo: Placebo Comparator |
Drug: placebo
placebo, oral capsule, single dose
|
The primary endpoint of the study is to determine the maximum tolerated dose (MTD) of CHF5074 after single oral administration to young healthy male volunteers.
The secondary objective of this study is to evaluate the pharmacokinetics of CHF5074 after single oral administration to young healthy male volunteers. The secondary endpoint of this study is to verify if CHF5074 plasma levels (Cmax and AUC0-t) increase proportionally with the dose (dose-linearity).
The exploratory objective of this study is to evaluate the pharmacodynamics of CHF5074 after single oral administration to young healthy male volunteers. The respective exploratory endpoint is to assess the relationship between individual maximum CHF5074 plasma concentrations and corresponding A-beta42 plasma concentrations corrected for baseline A-beta42 levels.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Iberica Clinical Research Center | |
Eatontown, NJ 07724, New Jersey, United States, 07724 |
Principal Investigator: | Joel S Ross, MD, FACP | Iberica Clinical Research Center |
Responsible Party: | Chiesi Pharmaceuticals Inc. ( Steven E. Linberg, Managing Director ) |
Study ID Numbers: | CCD-0814-PR-0008 |
Study First Received: | July 31, 2009 |
Last Updated: | September 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00954252 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Healthy |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |