Healthy
Conditions
Brief summary
The purpose of this study is to assess the pharmacokinetics of single-dose evening administration of JNJ-42847922 in elderly non-Asian adults compared with weight- and gender-matched young healthy non-Asian adults and to assess the pharmacokinetics of single-dose evening administration of JNJ-42847922 in healthy Japanese adults.
Interventions
DRUGJNJ-42847922 10 milligram (mg)
JNJ-42847922 will be administered as single tablet of 10 mg, orally, once on Day 1.
JNJ-42847922 will be administered as 1 tablet of 20 mg, orally, once on Day 1.
JNJ-42847922 will be administered as 2 tablets of 20 mg, orally, once on Day 1.
DRUGJNJ-42847922 60 or 80 mg
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.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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 healthy non-Asian adults 18 to 45 years old, inclusive, matched to elderly participants in the same cohort by gender and body weight (plus \[+\] or minus \[-\]5 kilogram \[kg\]); In Group C: For each cohort, 10 healthy Japanese adults 20 to 60 years old, inclusive, who have resided outside of Japan for less than or equal to (\<=)10 years, have parents and maternal and paternal grandparents who are Japanese, who primarily consume a Japanese diet, with 5 participants of each sex * Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study * Group B and Group C: If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day 1 of the treatment period * Group B and Group C: If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after the last study drug administration * If a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug * Has body mass index (BMI) (weight kilogram\[kg\]/height\^2 meter\[m\]\^2) between 18 and 30 kg/m2 (inclusive) with a body weight not less than 50 kg for non-Asian subjects (Group A and Group B) and not less than 45 kg for Japanese subjects (Group C)
Exclusion criteria
* Received a known inhibitor of cytochrome P450 3A4 (CYP3A4) or CYP2C9 activity within 28 days or a period less than 5 times the drugs half-life; whichever is longer, before the first dose of the study drug is scheduled * Consumption of products containing grapefruit or Seville oranges within 28 days before the first dose of the study drug is scheduled * Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled * Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug) * Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of JNJ-42847922 | Day 1 (Pre-dose) up to Day 3 | The Cmax is the maximum observed plasma concentration. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of JNJ-42847922 | Day 1 (Pre-dose) up to Day 3 | The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-42847922 | Day 1 (Pre-dose) up to Day 3 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events and serious adverse events as a measure of safety and tolerability | Baseline up to 10 days after last dose of study drug (Day 14) |
Countries
United States
Outcome results
None listed