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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01986491 | A Study of Solid Formulations of JNJ-39393406 in Healthy Male Participants | PHASE1 | COMPLETED | 20 | — | — | May 1, 2009 | Aug 1, 2009 | Nov 18, 2013 | 1 | Belgium |
Maximum plasma concentration of JNJ 39393406, determined by visual inspection of the data
Time to reach the maximum plasma concentration, determined by visual inspection of the data
| Arm | Type | Description |
|---|---|---|
| Part 1; Period 1 | EXPERIMENTAL | Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks. 30 mg of solid X, 120 mg of solid Y, 30 mg of solid Y, and 120 mg of solid X. |
| Part 1; Period 2 | EXPERIMENTAL | Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks. 30 mg of solid Y, 30 mg of solid X, 120 mg of solid X and 120 mg of solid Y. |
| Part 1; Period 3 | EXPERIMENTAL | Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 120 mg of solid X, 30 mg of solid Y, 120 mg of solid Y, and 30 mg of solid X. |
| Part 1; Period 4 | EXPERIMENTAL | Three participants will receive JNJ 39393406 of 2 different solid formulations (X and Y) with 2 different doses (30 mg and 120 mg) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 120 mg of solid Y, 120 mg of solid X, 30 mg of solid X, and 30 mg of solid Y. |
| Part 2; Period 1 | EXPERIMENTAL | Four participants will receive 30 mg of JNJ 39393406 of 2 different formulations (solid formulation selected from Part 1 and solution) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 30 mg of solid formulation, and 30 mg of solution. |
| Part 2; Period 2 | EXPERIMENTAL | Four participants will receive 30 mg of JNJ 39393406 of 2 different formulations (solid formulation selected from Part 1 and solution) in following sequence (on Day 1 of each sequence) with a washout period of 1-2 weeks: 30 mg of solution, and 30 mg of solid formulation. |
| Part 3 | EXPERIMENTAL | Eight participants (same participants from Part 2) will receive JNJ 39393406 (dose will likely be 30 mg, or another multiple of the 30 mg solid dose form selected in Part 1, but not higher than 210 mg) from Days 1 to 7. |
| Name | Type | Description |
|---|---|---|
| JNJ 39393406 30 mg solid X | DRUG | Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth). |
| JNJ 39393406 30 mg solid Y | DRUG | Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth). |
| JNJ 39393406 120 mg solid X | DRUG | Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth). |
| JNJ 39393406 120 mg solid Y | DRUG | Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth). |
| JNJ 39393406 30 mg solution | DRUG | Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth). |
Inclusion Criteria: * Healthy male participants * Body mass index (BMI) between 18 and 30 kg/m2 (BMI is calculated as weight \[kilogram\] divided by square of height \[meter\]) * Willing to adhere to the prohibitions and restrictions specified in the protocol * Must have signed an informed consent ...