Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects (CT02)
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ClinicalTrials.gov Identifier: NCT01203384 |
Recruitment Status
:
Completed
First Posted
: September 16, 2010
Last Update Posted
: February 10, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: CHF5074 1x Drug: CHF5074 2x Drug: CHF5074 3x Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: CHF5074 1x
oral tablet, multidose
|
Drug: CHF5074 1x
oral tablet, 1x, once a day in the morning for 14 days
|
Experimental: CHF5074 2x
oral tablet, multidose
|
Drug: CHF5074 2x
oral tablet, 2x, once a day in the morning for 14 days
|
Experimental: CHF5074 3x
oral tablet, multidose
|
Drug: CHF5074 3x
oral tablet, 3x, once a day in the morning for 14 days
|
Placebo Comparator: Placebo
placebo, oral tablet, multidose
|
Drug: Placebo
oral tablet, placebo, once a day in the morning for 14 days
|
- Adverse Events [ Time Frame: from Screening through Day 18 ]
- Dose linearity of CHF5074 plasma levels (Cmax) [ Time Frame: Day -1 through Day 18 ]
- Dose linearity of CHF5074 plasma levels (AUC 0-t) [ Time Frame: Day -1 through Day 18 ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests.
Exclusion Criteria:
- Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
- Abnormal results of liver function tests, renal function tests or thyroid tests performed at screening.
- Significant allergic conditions that require medical treatment
- Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
- Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.

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): NCT01203384
United States, New Jersey | |
Iberica Clinical Research Center | |
Eatontown, New Jersey, United States, 07724 |
Principal Investigator: | Magdy L Shenouda, MD | Iberica Clinical Research Center |
Responsible Party: | CERESPIR |
ClinicalTrials.gov Identifier: | NCT01203384 History of Changes |
Other Study ID Numbers: |
CCD-0913-PR-0038 |
First Posted: | September 16, 2010 Key Record Dates |
Last Update Posted: | February 10, 2015 |
Last Verified: | February 2015 |
Additional relevant MeSH terms:
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |