A Study to Assess the Effects of Age and Gender on the Pharmacokinetics of JNJ-42847922 in Healthy Adults

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-42847922 40 mg; Drug: JNJ-42847922 60 or 80 mg; Drug: JNJ-42847922 20 mg; Drug: JNJ-42847922 10 milligram (mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02837692

CR108176

42847922EDI1014 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: JNJ-42847922 10 milligram (mg)

Cohort 2

Experimental group

Description:

Participants assigned to Cohort 2 group A, group B and group C will receive JNJ-42847922 20 mg, 3 hours after completing dinner.

Treatment:

Drug: JNJ-42847922 20 mg

Cohort 3

Experimental group

Description:

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.

Treatment:

Drug: JNJ-42847922 40 mg

Cohort 4

Experimental group

Description:

Participants assigned to Cohort 4 group B will receive JNJ-42847922 60 or 80 mg, 3 hours after completing dinner.

Treatment:

Drug: JNJ-42847922 60 or 80 mg