A Drug Interaction Study in Healthy Participants to Assess the Effect of Rifampin on the Pharmacokinetics of JNJ-42847922
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 5/6/2016 |
| Start Date: | January 2016 |
| End Date: | February 2016 |
An Open-Label Drug Interaction Study to Assess the Pharmacokinetics of JNJ-42847922 When Administered Alone and in Combination With Rifampin in Healthy Male and Female Subjects
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.
on the single-dose pharmacokinetics of JNJ-42847922 after oral administration to healthy
male and female participants.
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.
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.
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
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