Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ 39393406 solid X · 1 trial · 1 indication
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 ...
JNJ 39393406 solid X is an investigational small molecule developed by Johnson & Johnson. It is a solid formulation of JNJ 39393406 that has been studied in a Phase 1 clinical trial in healthy male participants. No therapeutic indication has been disclosed for this formulation.
JNJ 39393406 solid X is made by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. Johnson & Johnson is the developer of the compound and sponsored the clinical study of its solid formulations.
JNJ 39393406 solid X is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single Phase 1 trial of solid formulations of JNJ-39393406 has been completed, and no trials of this formulation are currently active.
JNJ 39393406 solid X was studied in one Phase 1 trial, NCT01986491, titled A Study of Solid Formulations of JNJ-39393406 in Healthy Male Participants. The trial enrolled 20 healthy male volunteers aged 18 years and older in Belgium and is completed.
The Phase 1 trial NCT01986491 was a controlled study of solid formulations of JNJ-39393406 in healthy male participants. It enrolled 20 participants, was randomized, and was not double blind. The study was conducted in Belgium and has been completed.