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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02837692 | A Study to Assess the Effects of Age and Gender on the Pharmacokinetics of JNJ-42847922 in Healthy Adults | PHASE1 | COMPLETED | 140 | — | — | Jun 8, 2016 | Sep 11, 2017 | Oct 30, 2017 | 2 | United States |
The Cmax is the maximum observed plasma concentration.
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Participants assigned to Cohort 1 group A (elderly non-Asian), group B (young healthy non-Asian) and group C (healthy Japanese) will receive JNJ-42847922 10 mg, 3 hours after completing dinner. |
| Cohort 2 | EXPERIMENTAL | Participants assigned to Cohort 2 group A, group B and group C will receive JNJ-42847922 20 mg, 3 hours after completing dinner. |
| Cohort 3 | EXPERIMENTAL | Participants assigned to Cohort 3 group A and group C will receive JNJ-42847922 40 mg, 3 hours after completing dinner. Participants in group B will receive JNJ-42847922 40 mg, 3 hours after completing dinner in Period 1, followed by at least 7 days washout period, further followed by JNJ-42847922 40 mg, immediately after completing dinner. |
| Cohort 4 | EXPERIMENTAL | Participants assigned to Cohort 4 group B will receive JNJ-42847922 60 or 80 mg, 3 hours after completing dinner. |
| Name | Type | Description |
|---|---|---|
| JNJ-42847922 10 milligram (mg) | DRUG | JNJ-42847922 will be administered as single tablet of 10 mg, orally, once on Day 1. |
| JNJ-42847922 20 mg | DRUG | JNJ-42847922 will be administered as 1 tablet of 20 mg, orally, once on Day 1. |
| JNJ-42847922 40 mg | DRUG | JNJ-42847922 will be administered as 2 tablets of 20 mg, orally, once on Day 1. |
| JNJ-42847922 60 or 80 mg | DRUG | JNJ-42847922 will be administered as 3 or 4 tablets of 20 mg, orally, once on Day 1. Dose to be determined from Cohort 3, Period 1. |
Inclusion Criteria: * In Group A: For each cohort, 10 elderly non-Asian adults greater than or equal to (\>=)65 years old, with at least 2 participants \>=70 years and \<75 years old, at least 2 participants \>=75 years old, with 5 participants of each sex; In Group B: For each cohort, 10 young hea...