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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01840501 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42721458 in Healthy Male Participants | PHASE1 | COMPLETED | 108 | — | — | Apr 1, 2013 | Apr 1, 2014 | May 6, 2014 | 1 | Belgium |
Number of participants with adverse events will be used as a measure of safety and tolerability.
| Arm | Type | Description |
|---|---|---|
| Part 1: Panel 1 (0.1 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 0.1 mg of JNJ-42721458. |
| Part 1: Panel 2 (0.3 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 0.3 mg of JNJ-42721458. |
| Part 1: Panel 3 (1.0 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 1.0 mg of JNJ-42721458. |
| Part 1: Panel 4 (2.5 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 2.5 mg of JNJ-42721458. |
| Part 1: Panel 5 (5.0 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 5.0 mg of JNJ-42721458. |
| Part 1: Panel 6 (10.0 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 10.0 mg of JNJ-42721458. |
| Part 1: Panel 7 (20.0 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive a single dose of 20.0 mg of JNJ-42721458. |
| Part 1: Panel 8 | EXPERIMENTAL | 6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-7 in Part 1. |
| Part 1: Panel 9 | EXPERIMENTAL | 6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-8 in Part 1. |
| Part 1: Panel 10 | EXPERIMENTAL | 6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-9 in Part 1. |
| Part 1: Placebo | PLACEBO_COMPARATOR | 2 participants from each panel will receive a single dose of placebo. |
| Part 2: Panel 1 (5.0 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive multiple doses of 5.0 mg of JNJ-42721458. |
| Part 2: Panel 2 (10.0 mg JNJ-42721458) | EXPERIMENTAL | 6 participants will receive multiple doses of 10.0 mg of JNJ-42721458. |
| Part 2: Panel 3 | EXPERIMENTAL | 6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-2 in Part 2. |
| Part 2: Panel 4 | EXPERIMENTAL | 6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-3 in Part 2. |
| Part 2: Panel 5 | EXPERIMENTAL | 6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-4 in Part 2. |
| Part 2: Panel 6 | EXPERIMENTAL | 6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-5 in Part 2. |
| Part 2: Placebo | PLACEBO_COMPARATOR | 2 participants from each panel will receive multiple doses of placebo. |
| Name | Type | Description |
|---|---|---|
| JNJ-42721458 (single dose) | DRUG | JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg. |
| JNJ-42721458 (multiple doses) | DRUG | JNJ-42721458 will be administered subcutaneously (an injection under the skin) once daily, starting with a dose of 5.0 mg. |
| Placebo (single dose) | DRUG | Matching placebo will be administered subcutaneously (an injection under the skin) as a single dose in Part 1. |
| Placebo (multiple doses) | DRUG | Matching placebo will be administered subcutaneously (an injection under the skin) once daily for 10 days in Part 2. |
Inclusion Criteria: * Body mass index (weight kg/m2) between 18 and 30 kg/m2, and body weight not less than 50 kg * Participant is judged to be generally in good health based on medical history, physical examination, vital signs and laboratory safety tests * Blood pressure between 90 and 135 mmHg s...