A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Open-label, 4-Period Crossover Study in Healthy Subjects to Assess the Food Effect on a Single Dose of JNJ-64417184 Administered as an Oral Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04258189
• Other study ID #: CR108752
• Secondary ID: 2019-004189-1664
• Status: Completed
• Phase: Phase 1
• Start date: February 11, 2020
• Est. completion date: August 5, 2020

Study information

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

Clinical Trial Summary

The purpose of this study is to assess the food effect on the single-dose pharmacokinetic (PK) of the JNJ-64417184 oral solution, administered as 2 different formulations, in healthy adult participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 5, 2020
• Est. primary completion date: August 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Must have a body mass index (BMI; weight [kg]/height^2 [m^2]) between 18.0 and 30.0 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg at screening

• Healthy on the basis of physical examination, medical and surgical history, and vital signs 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

• Healthy on the basis of clinical laboratory tests performed at screening

• Must have a normal 12-lead electrocardiogram (ECG) (triplicate) at screening

• Female participant must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta- hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1

Exclusion Criteria:

• History of liver or renal dysfunction 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 type-1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening

• A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-64417184
Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit	Merksem

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 the maximum observed plasma analyte concentration.	Up to Day 6
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 area under the plasma analyte concentration-time curve (AUC) from time 0 to time of the last quantifiable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.	Up to Day 6
Primary	Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-64417184	AUC (0-infinity) is the area under the plasma analyte concentration-time curve (AUC) from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable (non-BQL) analyte concentration; and lambda(z) is apparent terminal elimination rate constant.	Up to Day 6
Secondary	Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment.	Up to 28 days
Secondary	Acceptability of the JNJ-64417184 Formulation as Assessed by Participant	The acceptability of the JNJ-64417184 formulations will be assessed by the participants using a questionnaire designed to rate the taste and smell as well as the overall acceptability of the formulations. The questionnaire will consist of a visual analogue scale to rate 5 items (sweetness, bitterness, aroma type, aroma strength, and smell) as well as overall acceptability.	Up to 28 days