Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects

Alzheimer's Disease Clinical Trial

— CT03  

Official title:

Randomized, Balanced, Single Dose, Cross-Over Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258452
• Other study ID #: CCD-1013-PR-0052
• Status: Completed
• Phase: Phase 1
• First received: December 9, 2010
• Last updated: February 9, 2015
• Start date: February 2011
• Est. completion date: March 2011

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

To evaluate the effects of a high-calorie high-fat meal on the extent and rate of absorption of CHF 5074 after single oral administration in young healthy male volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• 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.

• Subject has a body mass index between 18 and 30 kg/m^2, inclusive.

Exclusion Criteria:

• Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.

• Abnormal result 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: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• CHF 5074
Drug is administered to subject in a fasting state
• CHF 5974
Drug is administered to subject after consumption of a high fat, high calorie meal

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	area under the curve of plasma CHF 5074 levels from 0 to 96 hours (AUC 0-96)		from Day 1 to Day 5	No
Primary	peak CHF 5074 plasma concentration (Cmax)		from Day 1 to Day 5	No
Secondary	the time of occurrence of Cmax (Tmax)		from Day 1 to Day 5	No