Status:
COMPLETED
A First-in-Human Study of JNJ-28431754 in Healthy Male Volunteers
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and or the pharmacodynamics (PD) of single oral doses of JNJ-28431754 in healthy male volunteers. The study wil...
Detailed Description
This is a single-center study that will be conducted in two Parts (Part 1 and Part 2). Volunteers may participate in Part 1 or Part 2 of the study but not in both Part 1 and Part 2. Part 1 of the stud...
Eligibility Criteria
Inclusion
- Have body mass index (BMI) between 20.0 and 29.9 kg/m2 inclusive
- Be a non-smoker or non-tobacco user (not smoked cigarettes or used tobacco-containing products for at least 6 months prior to screening)
- Have competency in speaking and comprehending the language where the study will be conducted
Exclusion
- Have history, or family history of bleeding or coagulation disorders or history of disorders that are potential causes of occult (test positive for fecal blood test without visible blood in feces) gastrointestinal bleeding
- Have currently active skin disorders
- Have history of renal or urinary tract diseases
- Have history of having chronically taken (daily administration for more than 7 days) oral steroids, topical iodine, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants or other drugs known to interfere with blood clotting within 3 months of study start, or anticipates a need to take any of these during the course of the study
- Have history of recent major surgery (within 6 months of study start)
- Have history of recent travel (within 6 months) to locations that may predispose to the acquisition of communicable illnesses (e.g., parasitic or water-borne illnesses in developing tropical regions)
- Have recent history of alcohol or drug abuse within 6 months prior to screening
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01177150
Start Date
November 1 2006
End Date
April 1 2007
Last Update
August 11 2010
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