The purpose of this study is to evaluate the effect of single and multiple dose (once daily for 7 days) oral JNJ-64417184 and JNJ-53718678 on the pharmacokinetic (PK) of single and multiple-dose (once daily for 7 days) oral JNJ 53718678 and JNJ-64417184, respectively when coadministered to healthy adult participants under fed conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.
JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, Netherlands
Observed Plasma Analyte Concentration (Ctrough) of JNJ-53718678
Ctrough is defined as observed plasma analyte concentration just prior to the beginning of a dosing interval.
Time frame: Day 2, 3, 4, 5 and 6: predose; Day 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose
Ctrough of JNJ-64417184
Ctrough is defined as observed plasma analyte concentration just prior to the beginning of a dosing interval.
Time frame: Day 2, 3, 4, 5 and 6: predose; Day 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-53718678
Cmax is defined as maximum observed plasma analyte concentration.
Time frame: Day 1 and 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose
Cmax of JNJ-64417184
Cmax is defined as maximum observed plasma analyte concentration.
Time frame: Day 1 and 7: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 18 hours postdose
Area Under the Plasma Concentration-time Curve from Time of Administration up to 24 Hours Postdose (AUC[24h]) of JNJ-53718678
AUC24h is defined as AUC from time 0 to 24 hours postdose.
Time frame: Up to 24 hours postdose
AUC24h of JNJ-64417184
AUC24h is defined as AUC from time 0 to 24 hours postdose.
Time frame: Up to 24 hours postdose
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: Up to 42 days