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This study will assess the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and pharmacodynamics (explores what a drug does to the body) of single doses of JNJ-38431055, sitagliptin, and co-administration of JNJ-38431055 and sitagliptin in healthy overweight or obese adult male volunteers.
This is a double-blind (neither physician or volunteer knows the name of the assigned study drug), placebo controlled (substance containing no medication), study in healthy, overweight or obese adult male volunteers. For each volunteer, the study consists of a screening phase (up to 30 days), a treatment phase during which volunteers will receive 4 study treatments in a randomized (study sequence assigned by chance) sequence (28 days), and a follow-up phase (10 days). During the treatment phase there will be at least 7 days between each of the 4 treatments. The four treatments will be JNJ-38431055, sitagliptin, JNJ-38431055 and sitagliptin, and placebo. The following safety evaluations will be taken throughout the study: Electrocardiogram (an ECG is a painless procedure that gives a picture of the electrical activity of the heart), blood pressure, heart rate, and blood samples for laboratory tests. The primary outcome will be the effect of JNJ-38431055 and sitagliptin on glucagon like peptide-1 (GLP-1) levels. Study drug will be administered as single oral doses separated by at least 7 days. The four treatments will be JNJ-38431055, sitagliptin, JNJ-38431055 and sitagliptin, and placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | JNJ-38431055 Liquid suspension of JNJ-38431055 administered as a single dose |
|
| 002 | Active Comparator | Sitagliptin 100 mg Capsule containing 100 mg of sitagliptin administered as a single dose |
|
| 003 | Experimental | JNJ-38431055 + Sitagliptin 100 mg Liquid suspension of JNJ-38431055 administered as a single dose and capsule containing 100 mg of sitagliptin administered as a single dose |
|
| 004 | Placebo Comparator | Placebo Placebo suspension and placebo capsule administered as single doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-38431055 | Drug | Liquid suspension of JNJ-38431055 administered as a single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| GLP-1 levels after a standard meal | 0-4 hours after the standard meal |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetics of JNJ-38431055 administered alone and in combination with sitagliptin. | 24 hours after dosing | |
| Assess the effect of JNJ-38431055 on appetite and satiety using a visual analogue scale (VAS) | Within 24 hours of dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lincoln | Nebraska | United States |
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| Sitagliptin 100 mg |
| Drug |
Capsule containing 100 mg of sitagliptin administered as a single dose |
|
| JNJ-38431055 + Sitagliptin 100 mg | Drug | Liquid suspension of JNJ-38431055 administered as a single dose, and capsule containing 100 mg of sitagliptin administered as a single dose |
|
| Placebo | Drug | Placebo suspension and placebo capsule administered as single doses |
|
| Assess the safety and tolerability of JNJ-38431055 administered alone and in combination with sitagliptin as measured by occurrence of adverse events, ECGs, vital signs, and safety laboratory measurements. | From screening visit through follow-up visit |
| Assess incremental glucose changes after a meal tolerance test (MTT) | 0-4 hours after MTT |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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