The main purpose of this study is to evaluate the relative bioavailability of JNJ-64417184, formulated as a test formulation (tablet) compared to a reference formulation (suspension), administered orally in a fasted state, in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
Participants will receive 600 mg of JNJ-64417184 as oral tablet.
Participants will also receive JNJ-64417184 600 mg as oral suspension.
PRA Health Sciences Salt Lake City Clinic
Salt Lake City, Utah, United States
Relative Bioavailability of JNJ-64417184
The relative bioavailability based on Cmax, AUC(0last), and AUC(0-infinity) will be estimated as 100\*Test/Reference where Test is tablet formulation of JNJ-64417184 and Reference is suspension formulation of JNJ-64417184 administered orally in a fasted state.
Time frame: Day 1,8,15:Predose, 0.5,1,2,3,4,6,8,10,12 and 18 hours (hrs) postdose; Day 2,9,16:24,36hrs postdose; Day 3,10,17:48 hrs postdose; Day 4,11,18:72hrs postdose; Day 5,12,19:96hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21
Plasma Concentration of JNJ-64417184 in Fasted Conditions
Plasma concentration of JNJ-64417184 will be determined when administered as suspension under fasted conditions.
Time frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21
Plasma Concentration of JNJ-64417184 in fed and Fasted Conditions
Plasma concentration of JNJ-64417184 will be determined when administered as tablet under fed and fasted conditions.
Time frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184 in fed State
Cmax is defined as maximum observed plasma analyte concentration of JNJ-64417184 in fed state.
Time frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21
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Area Under the Plasma Analyte Concentration- time Curve from time 0 to time of the last Quantifiable Concentration (AUC [0-last]) in fed State
AUC (0-last) is defined as area under the plasma analyte concentration- time curve (AUC) from time 0 to time of the last quantifiable concentration of JNJ-64417184 in fed state.
Time frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21
Area Under the Plasma Analyte Concentration-time Curve From time 0 to Infinite time (AUC [0-infinity]) in fed State
AUC (0-infinity) is defined as area under the plasma analyte concentration-time curve (AUC) from time 0 to infinite time of JNJ-64417184 in fed state.
Time frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184 in Fasted State
Cmax is defined as maximum observed plasma analyte concentration of JNJ-64417184 in fasted state.
Time frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21
Area Under the Plasma Analyte Concentration- time Curve from time 0 to time of the last (AUC [0-last]) Quantifiable Concentration in Fasted State
AUC (0-last) is defined as area under the plasma analyte concentration- time curve (AUC) from time 0 to time of the last quantifiable concentration of JNJ-64417184 in fasted state.
Time frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21
Area Under the Plasma Analyte Concentration-time Curve From time 0 to Infinite time (AUC [0-infinity]) in Fasted State
AUC (0-infinity) is defined as area under the plasma analyte concentration-time curve (AUC) from time 0 to infinite time of JNJ-64417184 in fasted state.
Time frame: Day 1,8,15:Predose, 0.5, 1, 2, 3, 4, 6 ,8, 10, 12, and 18 hrs postdose; Day 2, 9, 16: 24, 36 hrs postdose; Day 3, 10, 17: 48 hrs postdose; Day 4, 11, 18: 72hrs postdose; Day 5, 12, 19: 96 hrs postdose;Day 6, 13, 20: 120hrs postdose up to Day 21
Number of Participants with Adverse Event as Measure of Safety and Tolerability
An adverse event is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Approximately 21 Days