Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-40411813: Formulation A · 1 trial · 1 indication
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
This pharmacokinetics parameter will be analyzed for 3 formulations of JNJ-40411813: Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet; and Formulation C: nanosuspension formulation.
This pharmacokinetics parameter will be analyzed for solid formulation of JNJ-40411813.
This pharmacokinetics parameter will be analyzed for solid formulation of JNJ-40411813.
This pharmacokinetics parameter will be analyzed for solid formulation of JNJ-40411813.
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | Participants will receive single dose of all the 3 formulations of JNJ-40411813 (Formulation A: hard gelatin capsule filled with beads; Formulation B: immediate release tablet, and Formulation C: Nanosuspension formulation) without food in 3 periods (Period 1, Period 2, and Period 3). The sequences will be based on a computer-generated randomization schedule prepared by the sponsor before the study. Each period will be separated by a wash out period (no treatment) of at least 1 week. |
| Part 2 | EXPERIMENTAL | Participants will receive single dose of the selected solid dose formulation of JNJ-40411813 (Formulation A or Formulation B) from Part 1 without food and with food in 2 periods (Period 1 and Period 2). The sequences will be based on a computer generated randomization schedule prepared by the sponsor before the study. Each period will be separated by a wash out period of at least 1 week. |
| Part 3 | EXPERIMENTAL | Participants will receive single dose of the selected solid dose formulation of JNJ-40411813 (Formulation A or Formulation B) from Part 1 on two occasions (Day 1 and Day 10) without food along with ketoconazole from Day 6 to Day 14 with food. |
| Name | Type | Description |
|---|---|---|
| JNJ-40411813: Formulation A | DRUG | Participants will receive JNJ-40411813 100 mg hard gelatin capsule orally (by mouth) as a single dose for Part 1 (Period 1, Period 2, and Period 3). If selected this formulation from Part 1, participants will receive this formulation at the dose of 50 mg to 150 mg orally without food and with food in Part 2 (Period 1, Period 2); and at the dose of 50 mg to 150 mg orally without food on Day 1 and Day 10 in Part 3. |
| JNJ-40411813: Formulation B | DRUG | Participants will receive JNJ-40411813 100 mg immediate release tablet orally as a single dose for Part 1 (Period 1, Period 2, and Period 3). If selected this formulation from Part 1, participants will receive this formulation at the dose of 50 mg to 150 mg orally without food and with food in Part 2 (Period 1, Period 2); and at the dose of 50 mg to 150 mg orally without food on Day 1 and Day 10 in Part 3. |
| JNJ-40411813: Formulation C | DRUG | Participants will receive JNJ-40411813 100 mg nanosuspension orally as a single dose for Part 1 (Period 1, Period 2, and Period 3). |
| Ketoconazole | DRUG | Participants will receive ketoconazole 200 mg tablet orally twice daily with food from Day 6 to Day 14 in Part 3. |
Inclusion Criteria: * Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug * Body mass index (BMI) between 18 and 30 kg/m2 (BMI is calculated as weight \[kilogram\] divided by square of h...
JNJ-40411813: Formulation A is an investigational small molecule developed by Johnson & Johnson. It is a solid dosage formulation studied in a Phase 1 clinical trial in healthy male volunteers. The specific therapeutic indication for this formulation has not been disclosed.
JNJ-40411813: Formulation A is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker symbol JNJ. The company sponsored the Phase 1 trial evaluating this formulation.
JNJ-40411813: Formulation A is in Phase 1 clinical development. The single completed trial was a Phase 1 study, and no active trials are currently listed for this formulation. It is investigational and has not been approved by the FDA.
JNJ-40411813: Formulation A has been evaluated in one completed Phase 1 trial, NCT01932320. The study assessed relative bioavailability, food effect, and the effect of ketoconazole on the absorption of solid dosage formulations of JNJ-40411813. It enrolled 36 healthy male volunteers in Belgium.
NCT01932320 was a Phase 1 trial that evaluated the relative bioavailability, food effect, and the effect of ketoconazole on the rate and extent of absorption of solid dosage formulations of JNJ-40411813. The completed study enrolled 36 healthy male volunteers in Belgium and used a controlled, randomized design.