Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects

Alzheimer's Disease Clinical Trial

— CT02  

Official title:

Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203384
• Other study ID #: CCD-0913-PR-0038
• Status: Completed
• Phase: Phase 1
• First received: September 15, 2010
• Last updated: February 9, 2015
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2015
• Source: CERESPIR
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• CHF5074 1x
oral tablet, 1x, once a day in the morning for 14 days
• CHF5074 2x
oral tablet, 2x, once a day in the morning for 14 days
• CHF5074 3x
oral tablet, 3x, once a day in the morning for 14 days
• Placebo
oral tablet, placebo, once a day in the morning for 14 days

Locations

Country	Name	City	State
United States	Iberica Clinical Research Center	Eatontown	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
CERESPIR

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		from Screening through Day 18	Yes
Secondary	Dose linearity of CHF5074 plasma levels (Cmax)		Day -1 through Day 18	No
Secondary	Dose linearity of CHF5074 plasma levels (AUC 0-t)		Day -1 through Day 18	No