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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01520142 | Safety, Tolerability and Pharmacodynamic Activity of JNJ-26528398 in Healthy Male Participants | PHASE1 | COMPLETED | 19 | — | — | Nov 1, 2011 | Apr 1, 2012 | Jun 24, 2013 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| JNJ-26528398 | DRUG | In Study Part 1, the participant will receive an oral solution of JNJ-26528398 3 mg once daily for 7 days. The same dosing regimen is planned for Part 2, but may be adjusted (lower dose and/or fewer dosing days) based on the data from Part 1. |
| Placebo | DRUG | In both Study Part 1 and Part 2, the participant will receive an oral solution of matching placebo once daily for up to 7 days. |
Inclusion Criteria: * Nonsmoker * Be in good health on the basis of physical examination, medical history, and electrocardiogram (ECG) * Must have good exercise tolerance * Have a body mass index of 18-29 kg/m2, inclusive, and body weight between 60 and 85 kg, inclusive * Have a history of consiste...