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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01054352 | A Single and Multiple Dose Study to Explore the Safety of JNJ-38224342 in Healthy Patients and Patients With Seasonal Allergies | PHASE1 | COMPLETED | 182 | — | — | Feb 1, 2010 | Mar 1, 2011 | Sep 4, 2013 | 1 | Canada |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | JNJ38224342/placebo one of six (6) single ascending doses (25 100 300 600 1250 or 2000 mg) of JNJ 38224342 or matching placebo up to four (4) additional cohorts consisting of healthy male volunteers may be added |
| 002 | EXPERIMENTAL | JNJ38224342/placebo multiple ascending oral doses (100 250 500 750 mg) of JNJ 38224342 or matching placebo administered for 14 consecutive days in healthy male or female volunteers.up to four (4) additional cohorts consisting of healthy male or female volunteers may be added |
| 003 | EXPERIMENTAL | JNJ38224342 single oral 100mg dose of JNJ 38224342 as a solution versus a single oral dose of JNJ 38224342 as a capsule formulation with and without food in healthy male volunteers |
| 004 | EXPERIMENTAL | JNJ38224342/placebo multiple oral doses of JNJ38224342 or matching placebo administered for up to 14 consecutive days in male and female volunteers number of days dosed and actual dose levels food requirements and regimens will be determined based on the data from Parts 1 2 and 3. |
| Name | Type | Description |
|---|---|---|
| JNJ38224342 | DRUG | multiple ascending oral doses (100, 250, 500, 750 mg) of JNJ 38224342 or matching placebo, administered for 14 consecutive days in healthy male or female volunteers |
| JNJ38224342/placebo | DRUG | up to four (4) additional cohorts consisting of healthy male volunteers may be added |
Inclusion Criteria: * Non-smokers * If male, willing to use an acceptable method of birth control for duration of study and for 90 days post study * Females must be post menopausal, surgically sterilized and cannot be pregnant or lactating (all parts of study) * Have a clinical history of allergic ...