An Open-Label Single Dose Study to Assess the Effects of Age and Gender on the Pharmacokinetics of JNJ-42847922 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of JNJ-42847922
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Cohort 1
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.
干预措施: JNJ-42847922 10 milligram (mg) (Drug)
Cohort 2
Participants assigned to Cohort 2 group A, group B and group C will receive JNJ-42847922 20 mg, 3 hours after completing dinner.
干预措施: JNJ-42847922 20 mg (Drug)
Cohort 3
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.
干预措施: JNJ-42847922 40 mg (Drug)
Cohort 4
Participants assigned to Cohort 4 group B will receive JNJ-42847922 60 or 80 mg, 3 hours after completing dinner.
干预措施: JNJ-42847922 60 or 80 mg (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of JNJ-42847922
时间窗: 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
时间窗: 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-infinity]) of JNJ-42847922
时间窗: 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.
次要结局
- 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))