Diabetes Mellittus type II
Conditions
Interventions
Each subject is only allowed to participate after randomisation to one of the
cohorts.
During part 1, a one single dose of JNJ-28431754 or placebo is administered.
The extra group will be dosed, twi
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy, non-smoking males, aged 18-55 years
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability, pharmacokinetic and pharmacodynamic blood and urine tests, adverse events, safety laboratory parameters, vital signs, heart rate, ECG, alcohol breath test and continuously hearth rhythm (telemetry) and Fecal Occult Blood Test (FOBT). | — |
Countries
Netherlands
Outcome results
None listed