Overview

Safety, Pharmacokinetics and Pharmacodynamics Study of Treatment With CHF 5074 in Healthy Young Male Subjects

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to evaluate the safety and tolerability of single oral doses of CHF 5074 in young healthy male volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
CERESPIR
Treatments:
Flurbiprofen
Criteria
Inclusion Criteria:

- Subject's written informed consent is obtained prior to any study-related procedures.

- Subject is nonsmoking male between 18 and 45 years of age, inclusive.

- Subject has a body mass index between 18 and 30 kg/m2, inclusive.

- Subject is judged, by the investigator, 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 including complete hematology,
blood chemistry (glucose, creatinine, blood urea nitrogen, alanine aminotransferase,
aspartate aminotransferase, albumin, alkaline phosphatase, sodium, potassium), thyroid
function, urinalysis (glucose, hemoglobin, blood, proteins, pH) and fecal occult
blood.

- Subject understands the procedures and agrees to participate in the study program.

Exclusion Criteria:

- Subject is mentally or legally incapacitated.

- Subject has a history of any illness that, in the opinion of the investigator and
according to the protocol, might confound the results of the study or pose additional
risk in administering CHF5074 to the subject.

- Subject has a medical history (within the last 10 years) of major cardiovascular,
hepatic or renal disease.

- Subject has liver function test abnormalities with elevated AST or ALT greater than or
equal to 2 times upper limit of normal and/or elevated bilirubin greater than or equal
to 2 times upper limit of normal.

- Subject has renal function test abnormalities, including serum creatinine greater than
1.8 g/dL.

- Subject has abnormal fasting serum concentrations of TSH, T3 or T4.

- Subject has a positive result for fecal occult blood testing performed at screening.

- Subject has clinically significant abnormalities on physical examination, ECG or
laboratory tests carried out at screening.

- Subject has a history of a psychiatric disorder.

- Subject has significant allergic conditions that require medical treatment or has
known hypersensitivity to medications that could be activated by CHF5074 treatment.

- Subject is positive on testing for hepatitis B surface antigen, hepatitis C antibody
or HIV 1 or 2 antibodies.

- Subject has donated blood within the 1 month prior to screening.

- Subject has a history of alcohol or drug abuse in the past 12 months.

- Subject used any psychoactive, recreational or prescription drug within the 4 weeks
prior to study drug administration.

- Subject has used ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2
weeks prior to study drug administration.

- Subject has used any other over-the-counter drug within 1 week prior to study drug
administration Occasional treatment with acetaminophen or aspirin is permitted but
must be reported to the investigator. Vitamins are permitted.

- Subject is positive on urine drug screening for drugs of abuse (cannabinoids, cocaine,
opiates, amphetamines, barbiturates, benzodiazepines).

- Subject has evidence of alcohol on screening blood work and breathalyzer test.

- Subject does not agree to use a medically acceptable contraceptive (abstain from
sexual intercourse, or use a condom with spermicide) for 7 days after study drug
administration, or has not had a vasectomy at least 6 months prior to study
participation.

- Subject is unlikely to comply with the study protocol or unable to understand the
nature and scope of the study or the possible benefits or unwanted effects of the
study treatments.

- Subject has participated in another investigational study within 30 days prior to
screening.