A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants

NCT04208373 | Completed Phase 1

• 3 other identifiers: CR1087472019-003928-2064417184RSV1002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Analyte concentration (Cmax) of JNJ 64417184

  Cmax is defined as maximum observed plasma analyte.

  Predose up to 144 hours post dose

• Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ 64417184

  AUC (0-last) is defined as the area under the plasma analyte concentration- time curve (AUC) from time 0 to the time of the last measurable (non-below qualification limit) concentration.

  Predose up to 144 hours post dose

• Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ 64417184

  AUC (0-infinity) is defined as AUC from time 0 to infinite time, calculated as the sum of AUC(0-last) and C(last)/ lambda(z), wherein C(last) is the last observed quantifiable concentration; extrapolations of more than 20 percent (%) of the total AUC.

  Predose up to 144 hours post dose

Secondary Outcomes (1)

• Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability

  Up to 54 days

Study Arms (2)

Panel 1: JNJ 64417184 plus Itraconazole

EXPERIMENTAL

Participants will receive single oral dose of JNJ 64417184 on Day 1 followed by itraconazole once daily on Days 6 to 13 along with a single dose of JNJ 64417184 on Day 9 orally.

Drug: JNJ-64417184; Drug: Itraconazole

Panel 2: JNJ 64417184 plus Etravirine

EXPERIMENTAL

Participants will receive single oral dose of JNJ-64417184 on Day 1 followed by etravirine twice daily on Days 6 to 19 along with single dose of JNJ 64417184 on Day 15.

Drug: JNJ-64417184; Drug: Etravirine

Interventions

JNJ-64417184 DRUG

JNJ 64417184 tablets will be administered orally.

Panel 1: JNJ 64417184 plus Itraconazole; Panel 2: JNJ 64417184 plus Etravirine

Itraconazole DRUG

Itraconazole capsules will be administered orally

Panel 1: JNJ 64417184 plus Itraconazole

Etravirine DRUG

etravirine tables will be administered orally.

Panel 2: JNJ 64417184 plus Etravirine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)

Antwerp, 2060, Belgium

Location

MeSH Terms

Interventions

Itraconazole; etravirine

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 23, 2019
• Study Start: December 20, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)