A Drug Interaction Study in Healthy Participants to Assess the Effect of Rifampin on the Pharmacokinetics of JNJ-42847922

NCT02661893 | Completed Phase 1

• 2 other identifiers: CR10807742847922EDI1009
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of single- and multiple-dose of rifampin on the single-dose pharmacokinetics of JNJ-42847922 after oral administration to healthy male and female participants.

Conditions

Healthy

Keywords

Healthy; JNJ-42847922; Rifampin; Pharmacokinetics

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 1

  Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.

  Day 1

• Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 5

  Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.

  Day 5

• Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 12

  Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.

  Day 12

• Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 1

  Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.

  Day 1

• Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 5

  Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.

  Day 5

• Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 12

  Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.

  Day 12

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  up to Day 44

Study Arms (1)

JNJ-42847922 and Rifampin

EXPERIMENTAL

A single oral dose of 40 milligram (mg) (=2\*20 mg) dose of JNJ-42847922 on Day 1; A single oral dose of 40 mg (=2\*20 mg) dose of JNJ-42847922 dosed with one oral dose of rifampin 600 mg (2\*300 mg) on Day 5; A single oral dose of 40 mg (=2\*20 mg) dose of JNJ-42847922 dosed on Day 12, following once daily dosing of rifampin with an oral dose of rifampin 600 mg (2\*300 mg) on Days 5-12.

Drug: JNJ-42847922; Drug: Rifampin

Interventions

JNJ-42847922 DRUG

A single oral dose of 40 milligram (mg) (=2\*20 mg) dose of JNJ42847922 on Day 1, Day 5 and Day 12.

JNJ-42847922 and Rifampin

Rifampin DRUG

Oral dose of rifampin 600 mg (2\*300 mg) on Day 5 and once daily dosing of rifampin with an oral dose of rifampin 600 mg (2\*300 mg) on Days 5 to 12.

JNJ-42847922 and Rifampin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women of non-child-bearing potential between 18 and 60 years of age, inclusive; body mass index (BMI) between 18 and 30 kilogram (kg)/meter\^2, inclusive, and body weight of not less than 50 kg who are nonsmokers (current and for past 60 days)

You may not qualify if:

• History of or current clinically significant medical illness
• Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis
• Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG)
• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of the study drug is scheduled until completion of the study
• Received a known inhibitor of cytochrome P450 (CYP) 3A4 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

seltorexant; Rifampin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 25, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

US (1)