A Study to Assess the Effects of Age and Gender on the Pharmacokinetics of JNJ-42847922 in Healthy Adults
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 11/1/2017 |
Start Date: | June 8, 2016 |
End Date: | September 11, 2017 |
An Open-Label Single Dose Study to Assess the Effects of Age and Gender on the Pharmacokinetics of JNJ-42847922 in Healthy Adults
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.
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.
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
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