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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04208373
• Other study ID #: CR108747
• Secondary ID: 2019-003928-2064
• Status: Completed
• Phase: Phase 1
• Start date: December 20, 2019
• Est. completion date: March 10, 2020

Study information

• Verified date: March 2020
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-64417184
JNJ 64417184 tablets will be administered orally.
• Itraconazole
Itraconazole capsules will be administered orally
• Etravirine
etravirine tables will be administered orally.

Locations

Country	Name	City	State
Belgium	SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Analyte concentration (Cmax) of JNJ 64417184	Cmax is defined as maximum observed plasma analyte.	Predose up to 144 hours post dose
Primary	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
Primary	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	Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability	An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 54 days