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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01631487 | A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Participants | PHASE1 | COMPLETED | 86 | — | — | Jul 1, 2012 | Mar 1, 2013 | Jun 25, 2013 | 1 | United States |
| NCT01454245 | A Study to Evaluate the Bioavailability and Food Effect of JNJ-39439335 in Healthy Adult Male Volunteers | PHASE1 | COMPLETED | 43 | — | — | Jul 1, 2011 | Apr 1, 2012 | Jan 31, 2013 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Japanese Group 1: JNJ-39439335/placebo (Part 1) | EXPERIMENTAL | - |
| Japanese Group 2: JNJ-39439335/placebo (Part 1) | EXPERIMENTAL | - |
| Japanese Group 3: JNJ-39439335/placebo (Part 1) | EXPERIMENTAL | - |
| Caucasian Group 1: JNJ-39439335/placebo (Part 1) | EXPERIMENTAL | - |
| Caucasian Group 2: JNJ-39439335/placebo (Part 1) | EXPERIMENTAL | - |
| Caucasian Group 3: JNJ-39439335/placebo (Part 1) | EXPERIMENTAL | - |
| Japanese Group 1: JNJ-39439335/placebo (Part 2) | EXPERIMENTAL | - |
| Japanese Group 2: JNJ-39439335/placebo (Part 2) | EXPERIMENTAL | - |
| Japanese Group 3: JNJ-39439335/placebo (Part 2) | EXPERIMENTAL | - |
| 001 | EXPERIMENTAL | JNJ-39439335 Part 1:Type=1 unit=mg number=25 form=capsule route=oral use. One capsule (25 mg/day) taken once on Day 1 in 3 treatment periods. or Part 1:Type=2 unit=mg number=12.5 form=capsule route=oral use. Two capsules (25 mg/day) taken once on Day 1 in 3 treatment periods.,JNJ-39439335 Part 2:Type=2 unit=mg number=12.5 form=capsule route=oral use. Two capsules taken (25 mg/day) once on Day 1 in 2 treatment periods. |
| Name | Type | Description |
|---|---|---|
| JNJ-39439335 10 mg | DRUG | Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg. |
| JNJ-39439335 25 mg | DRUG | Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg. |
| JNJ-39439335 50 mg | DRUG | Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg. |
| Placebo | DRUG | Multiple (once daily for 21 days) oral doses of matching placebo. |
| JNJ-39439335 | DRUG | Part 2:Type=2, unit=mg, number=12.5, form=capsule, route=oral use. Two capsules taken (25 mg/day) once on Day 1 in 2 treatment periods. |
Inclusion Criteria: * Japanese or Caucasian participants * Nonsmoker * Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive, and body weight not less than 50 kg * Healthy on the basis of a physical examination, vital signs, hematology, coagulation, serum chemistry (including liver function tests) and...