A Study to Assess the Effects of Age and Gender on the Pharmacokinetics of JNJ-42847922 in Healthy Adults
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02837692
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
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)
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 4 JNJ-42847922 60 or 80 mg Participants assigned to Cohort 4 group B will receive JNJ-42847922 60 or 80 mg, 3 hours after completing dinner. Cohort 3 JNJ-42847922 40 mg 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 1 JNJ-42847922 10 milligram (mg) 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 JNJ-42847922 20 mg Participants assigned to Cohort 2 group A, group B and group C will receive JNJ-42847922 20 mg, 3 hours after completing dinner.
- Primary Outcome Measures
Name Time Method 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.
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.
Maximum Plasma Concentration (Cmax) of JNJ-42847922 Day 1 (Pre-dose) up to Day 3 The Cmax is the maximum observed plasma concentration.
- Secondary Outcome Measures
Name Time Method 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)