Clinical trial NCT04208373: A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants
Official title: A Phase 1, Open-label, Fixed-sequence, 2-Panel Study to Assess the Effects of Itraconazole and Etravirine on the Single-dose Pharmacokinetics of JNJ-64417184 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-12-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the effects of itraconazole or etravirine on the single-dose pharmacokinetics (PK) of JNJ 64417184 in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Body mass index (weight \[kg\]/height2 \[m\]2) between 18.0 and 30.0 kg/m2, extremes included, and body weight not less than 50 kg at screening
* Healthy on the basis of physical examination, medical and surgical history, and vital signs (systolic blood pressure, diastolic blood pressure, and pulse rate \[after the participant is supine for at least 5 minutes\], respiratory rate, and oral body temperature) performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Female participant must have a negative highly sensitive serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test on Day 1
* Female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 90 days after the last study drug intake
* Must not use nicotine-containing substances including tobacco products (example, cigarettes, e-cigarettes, cigars, chewing tobacco, gum, or patch) for at least 3 months prior to screening

Exclusion Criteria:

* History of liver or renal dysfunction (calculated creatinine clearance/estimated glomerular filtration rate (eGFR) less than (\<) 60 milliliter per minute (mL/min) at screening, calculated by the Modification of Diet in Renal Disease \[MDRD\] formula), significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
* - Past history of cardiac arrhythmias (example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
* Any evidence of heart block or bundle branch block at screening
* Current human immunodeficiency virus (HIV)-1 or HIV-2 infection (confirmed by antibodies) at screening
* History of hepatitis A virus immunoglobulin M antibody, hepatitis B surface antigen, or hepatitis C virus antibody positive, or other clinically active liver disease, or tests positive for hepatitis A virus immunoglobulin M antibody, hepatitis B surface antigen, or hepatitis C virus antibody at screening

Primary outcomes:
measure: Maximum Observed Plasma Analyte concentration (Cmax) of JNJ 64417184
timeFrame: Predose up to 144 hours post dose
measure: Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ 64417184
timeFrame: Predose up to 144 hours post dose
measure: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ 64417184
timeFrame: Predose up to 144 hours post dose
Secondary outcomes:
measure: Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
timeFrame: Up to 54 days
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: