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

NCT01258452 | Completed Phase 1

• 1 other identifier: CCD-1013-PR-0052
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• area under the curve of plasma CHF 5074 levels from 0 to 96 hours (AUC 0-96)

  from Day 1 to Day 5

• peak CHF 5074 plasma concentration (Cmax)

  from Day 1 to Day 5

Secondary Outcomes (1)

• the time of occurrence of Cmax (Tmax)

  from Day 1 to Day 5

Study Arms (2)

CHF 5074 (fed group)

EXPERIMENTAL

oral tablet, single dose

Drug: CHF 5974

CHF 5074 (fasting group)

EXPERIMENTAL

oral tablet, single dose

Drug: CHF 5074

Interventions

CHF 5074 DRUG

Drug is administered to subject in a fasting state

CHF 5074 (fasting group)

CHF 5974 DRUG

Drug is administered to subject after consumption of a high fat, high calorie meal

CHF 5074 (fed group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CERESPIR: lead

Study Sites (1)

Iberica Clinical Research Center

Eatontown, New Jersey, 07724, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

1-(3',4'-dichloro-2-fluoro(1,1'-biphenyl)-4-yl)cyclopropanecarboxylic acid

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Magdy L. Shenouda, MD

  Iberica Clinical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 13, 2010
• Study Start: February 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

US (1)