A Study to Assess the Effects of Itraconazole and Etravir... | NCT04208373

NCT04208373

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2019-003928-20	EudraCT Number
64417184RSV1002	Other Identifier	Janssen Research & Development, LLC

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
JNJ-64417184	Drug	JNJ 64417184 tablets will be administered orally.	Panel 1: JNJ 64417184 plus Itraconazole Panel 2: JNJ 64417184 plus Etravirine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Eligibility Module

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

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)		Antwerp		2060	Belgium

IPD Sharing Statement Module

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds