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Completed

NCT Number: NCT01258452

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Iberica Clinical Research Center

Eatontown, New Jersey, 07724, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHF 5074

Drug

Drug is administered to subject in a fasting state

CHF 5974

Drug

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

Primary outcomes

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

    Time frame: from Day 1 to Day 5

  2. peak CHF 5074 plasma concentration (Cmax)

    Time frame: from Day 1 to Day 5

Secondary outcomes

  1. the time of occurrence of Cmax (Tmax)

    Time frame: from Day 1 to Day 5

Sponsors and collaborators

Lead sponsor

CERESPIR

Industry

Registry information

Official study 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

Acronym: CT03

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 13, 2010
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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