Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01054118 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of JNJ-38431055, Sitagliptin, and Co-administration of JNJ-38431055 and Sitagliptin | PHASE1 | COMPLETED | 18 | — | — | Dec 1, 2009 | Feb 1, 2010 | Sep 4, 2013 | 1 | United States |
| NCT00910923 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-38431055 in Healthy Male Volunteers | PHASE1 | COMPLETED | 37 | — | — | Nov 1, 2008 | Apr 1, 2009 | Oct 6, 2009 | - | — |
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| JNJ-38431055 | DRUG | Liquid suspension of JNJ-38431055 administered as a single dose |
| 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 |
Inclusion Criteria: * Body Mass Index (BMI) between 27.0 and 38.0 kg/m2 (inclusive) * Healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests * Men must agree to use a double barrier method of birth control (e.g., condom fo...