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Completed

NCT Number: NCT01203384

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

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.

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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.

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.

Treatment and study plan

CHF5074 1x

Drug

oral tablet, 1x, once a day in the morning for 14 days

CHF5074 2x

Drug

oral tablet, 2x, once a day in the morning for 14 days

CHF5074 3x

Drug

oral tablet, 3x, once a day in the morning for 14 days

Placebo

Drug

oral tablet, placebo, once a day in the morning for 14 days

Primary outcomes

  1. Adverse Events

    Time frame: from Screening through Day 18

Secondary outcomes

  1. Dose linearity of CHF5074 plasma levels (Cmax)

    Time frame: Day -1 through Day 18

  2. Dose linearity of CHF5074 plasma levels (AUC 0-t)

    Time frame: Day -1 through Day 18

Sponsors and collaborators

Lead sponsor

CERESPIR

Industry

Registry information

Official study title

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

Acronym: CT02

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 16, 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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