Clinical trial NCT02661893: A Drug Interaction Study in Healthy Participants to Assess the Effect of Rifampin on the Pharmacokinetics of JNJ-42847922
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
JNJ-42847922
Rifampin
Pharmacokinetics
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-01-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 1
timeFrame: Day 1
measure: Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 5
timeFrame: Day 5
measure: Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 12
timeFrame: Day 12
measure: Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 1
timeFrame: Day 1
measure: Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 5
timeFrame: Day 5
measure: Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 12
timeFrame: Day 12
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: up to Day 44
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: