Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-38431055 in Healthy Male Volunteers
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This will be a single center study conducted in two parts. Part 1 will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of JNJ-38431055 in healthy male...
Detailed Description
The study includes 2 Parts and will be conducted at a single center. Part 1 is a randomized (study drug assigned by chance), double-blind (neither the volunteer or investigator knows the name of the a...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive)
- Healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests performed
- Volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion
- History of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant
- Smoker or tobacco user within the past 6 months
- History of recent major surgery (within 6 months of study start)
- Positive test for alcohol and/or drugs of abuse
- Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
- Any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00910923
Start Date
November 1 2008
End Date
April 1 2009
Last Update
October 6 2009
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