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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01650597 | A Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-42165279 in Healthy Male Participants | PHASE1 | COMPLETED | 29 | — | — | Aug 1, 2011 | May 1, 2012 | Jul 6, 2017 | 1 | Belgium |
As a measure of safety.
Cmax is defined as maximum plasma concentration of JNJ-42165279.
AUC is defined area under the plasma concentration time curve from 0 to t hours post dosing of JNJ-42165279.
| Arm | Type | Description |
|---|---|---|
| Part 1 - Panel 1 | EXPERIMENTAL | The participants will receive 3 or 4 ascending doses (2.5, 10, 30, 100, 250, 500 mg) of JNJ-42165279 and placebo during the study. |
| Part 1 - Panel 2 | EXPERIMENTAL | The participants will receive 3 or 4 ascending doses (2.5, 10, 30, 100, 250, 500 mg) of JNJ-42165279 and placebo during the study. |
| Part 2 (parallel)- additional cohort | EXPERIMENTAL | The participants will receive repeated daily dosing of 100 mg JNJ-42165279 or placebo for 6 consecutive days. |
| Name | Type | Description |
|---|---|---|
| JNJ-42165279 2.5 - 500 mg oral | DRUG | Type=exact number, unit=mg, numbers=2.5, 10, 30, 100, 250 and 500, form=suspension, route=oral use. One single dose administered orally. |
| Placebo | DRUG | Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally. |
| JNJ-42165279 100 mg oral | DRUG | Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally. |
Inclusion Criteria: * Has a body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg. * Must adhere to required contraception (subject and partner, if applicable) during the study and for 3 months after study * Must agree to not donate sperm during the study and for 3 months afte...