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

NCT ID: NCT02661893

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-02-29

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.

Detailed Description

This is an open-label, fixed-sequence, single-center, multiple-dose study in 14 healthy adults. All participants will receive a single oral dose of 40 milligram (mg) JNJ-42847922 on 3 separate occasions: Day 1 (JNJ-42847922 alone), Day 5 (JNJ-42847922 with a single dose of rifampin), and Day 12 (JNJ-42847922 in combination with steady-state rifampin). A daily dose of 600 mg (2 * 300 mg) rifampin will be administered from Day 5 through Day 12. Following JNJ-42847922 dosing, serial blood samples will be collected over 48 hours for the evaluation of plasma concentrations of JNJ-42847922 and its metabolites. Participants' safety will be monitored throughout the study.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JNJ-42847922 and Rifampin

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.

Group Type: EXPERIMENTAL

JNJ-42847922

Intervention Type: DRUG

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

Rifampin

Intervention Type: 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.

Interventions

JNJ-42847922

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

Intervention Type: DRUG

Rifampin

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Overland Park, Kansas, United States

Countries

United States

Other Identifiers

42847922EDI1009

Identifier Type: OTHER

Identifier Source: secondary_id

CR108077

Identifier Type: -

Identifier Source: org_study_id