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

NCT02837692 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10817642847922EDI1014
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax) of JNJ-42847922

  The Cmax is the maximum observed plasma concentration.

  Day 1 (Pre-dose) up to Day 3

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of JNJ-42847922

  The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

  Day 1 (Pre-dose) up to Day 3

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-42847922

  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.

  Day 1 (Pre-dose) up to Day 3

Secondary Outcomes (1)

• 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)

Study Arms (4)

Cohort 1

EXPERIMENTAL

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.

Drug: JNJ-42847922 10 milligram (mg)

Cohort 2

EXPERIMENTAL

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

Drug: JNJ-42847922 20 mg

Cohort 3

EXPERIMENTAL

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.

Drug: JNJ-42847922 40 mg

Cohort 4

EXPERIMENTAL

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

Drug: JNJ-42847922 60 or 80 mg

Interventions

JNJ-42847922 10 milligram (mg) DRUG

JNJ-42847922 will be administered as single tablet of 10 mg, orally, once on Day 1.

Cohort 1

JNJ-42847922 20 mg DRUG

JNJ-42847922 will be administered as 1 tablet of 20 mg, orally, once on Day 1.

Cohort 2

JNJ-42847922 40 mg DRUG

JNJ-42847922 will be administered as 2 tablets of 20 mg, orally, once on Day 1.

Cohort 3

JNJ-42847922 60 or 80 mg DRUG

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.

Cohort 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Unknown Facility

Cypress, California, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

MeSH Terms

Interventions

seltorexant

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: July 19, 2016
• Study Start: June 8, 2016
• Primary Completion: September 7, 2017
• Study Completion: September 11, 2017
• Last Updated: October 30, 2017

Record last verified: 2017-10

Locations

US (2)