A First-in-Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Escalating Oral Doses of JNJ 28431754 in Healthy Male Subjects
Completed
- Conditions
- Diabetes Mellittus type II10018424
- Registration Number
- NL-OMON30637
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 56
Inclusion Criteria
Healthy, non-smoking males, aged 18-55 years
Exclusion Criteria
Positive FOBT at screening or admission (Day -1)
Positive H. pylori IgG Ab test result from the Chemiluminescence Immunoassay or urea breath test, at screening
History of disorders that are potential causes of occult GI bleeding
History of, or currently active, significant illness or medical disorders
Male subjects who are not sterile and are unwilling to use condoms for the duration of the study (and until 90 days after the last dose of study medication).
Tested positive for serology: hepatitis B surface antigen (HBsAg), hepatitis C antibodies (anti-HCV) or human immunodeficiency virus (HIV) antibodies.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>safety and tolerability, pharmacokinetic and pharmacodynamic blood and urine<br /><br>tests, adverse events, safety laboratory parameters, vital signs, heart rate,<br /><br>ECG, alcohol breath test and continuously hearth rhythm (telemetry) and Fecal<br /><br>Occult Blood Test (FOBT).</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>