The purpose of this study is to assess the rate and extent of absorption of JNJ-64041575 by measuring ALS-008112 plasma concentrations following administration of a single oral dose of JNJ-64041575 given as 2 new concept formulations (oral suspension and tablet) compared to their respective current formulations under fasted conditions and to assess the effect of food on the pharmacokinetics of the 2 new concept formulations under fed condition in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Participants will receive 240 mg JNJ-64041575 under fasted and fed conditions in Panel 1 as current/new concept oral suspension formulation.
Participants will receive 250 mg JNJ-64041575 under fasted and fed conditions in Panel 2 as current/new concept oral tablet formulation.
Clinical Pharmacology Unit
Merksem, Belgium
Maximum Observed Plasma Concentration (Cmax) of ALS-008112 (JNJ-63549109)
Cmax is the maximum observed plasma concentration.
Time frame: Up to Day 8
Area Under Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last]) of ALS-008112 (JNJ-63549109)
Area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \[non BQL\]) concentration, calculated by linear trapezoidal summation.
Time frame: Up to Day 8
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ALS-008112 (JNJ-63549109)
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/ lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
Time frame: Up to Day 8
Time to Reach Maximum Concentration (Tmax) ALS-008112 (JNJ-63549109)
Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
Time frame: Up to Day 8
Apparent Terminal Elimination Rate Constant (lambda z) of ALS-008112 (JNJ-63549109)
Apparent terminal elimination rate constant, determined by linear regression using the terminal log linear phase of the log transformed concentration versus time curve.
Time frame: Up to Day 8
Apparent Terminal Elimination Half-life (t1/2term) of ALS-008112 (JNJ-63549109)
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda\[z\]).
Time frame: Up to Day 8
Maximum Observed Plasma Concentration (Cmax) of ALS-008144 (JNJ-64167896)
Cmax is the maximum observed plasma concentration.
Time frame: Up to Day 8
Time to Reach Maximum Concentration (Tmax) of ALS-008144 (JNJ-64167896)
Tmax defined as the actual sampling time to reach the maximum observed plasma concentration.
Time frame: Up to Day 8
Area Under Plasma Concentration Curve from time zero to the last quantifiable (AUC [0-last]) of ALS-008144 (JNJ-64167896)
AUC (0-last) defined as area under the plasma concentration time curve (AUC) from time 0 to the time of the last measurable (non below quantification limit \[non-BQL\]) concentration, calculated by linear trapezoidal summation.
Time frame: Up to Day 8
Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ALS-008144 (JNJ-64167896)
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time calculated as the sum of AUC (0-last) and C (0-last)/ lambda(z); wherein AUC (0-last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(0-last) is the last observed quantifiable concentration, and lambda (z) is elimination rate constant.
Time frame: Up to Day 8
Apparent Terminal Elimination Rate Constant (lambda z) of ALS-008144 (JNJ-64167896)
Apparent terminal elimination rate constant, determined by linear regression using the terminal log linear phase of the log transformed concentration versus time curve.
Time frame: Up to Day 8
Apparent Terminal Elimination Half-life (t1/2term) of ALS-008144 (JNJ-64167896)
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration time curve and calculated as 0.693/apparent terminal elimination rate constant (lambda\[z\]).
Time frame: Up to Day 8
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Safety and Tolerability
Time frame: Screening (28 days ) to Follow up Phase (10 to 14 days after last dose)
Taste of JNJ-64041575 following administration of different oral suspension formulations under fed and fasted conditions in healthy adult participants in Panel 1 (taste questionnaire)
Participants will complete a taste questionnaire within 5 to 15 minutes after study drug intake in each treatment period. For the taste questionnaire, a dichotomization will be made for the overall question, categorizing 'bad' and 'almost acceptable' versus 'acceptable' and 'good'.
Time frame: Day 1
Taste and Swallowability of JNJ-64041575 following administration of different oral tablet formulations under fed and fasted conditions in healthy adult participants in Panel 2 (taste and swallowability questionnaire)
A taste and swallowability questionnaire will be completed by the participant within 5 to 15 minutes after each study drug intake in each treatment period, to compare the taste and swallowability (tablets only) of JNJ-64041575 following administration of different oral formulations under fed and fasted conditions. For the taste questionnaire, a dichotomization will be made for the overall question, categorizing 'bad' and 'almost acceptable' versus 'acceptable' and 'good'. For the swallowability, a dichotomization will be made of 'slightly difficult' or worse versus 'neither difficult nor easy' or better. The results of the questionnaire will be transcribed into the e-Source by a member of the study-site personnel.
Time frame: Day 1
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