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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.
Clinical Pharmacology Unit
Merksem, Belgium
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184
Cmax is the maximum observed plasma analyte concentration.
Time frame: Up to Day 6
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.
Time frame: Up to Day 6
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.
Time frame: Up to Day 6
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.
Time frame: Up to 28 days
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.
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Time frame: Up to 28 days