The primary purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JNJ-64264681 in healthy participants after single and multiple oral doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
105
For all cohorts except the solid dose formulation cohort, JNJ-64264681 wlll be administered as oral solution. For the solid dose formulation cohort, JNJ-64264681 will be provided as capsules for oral administration.
Matching placebo to JNJ-64264681 will be administered as oral solution.
Clinical Pharmacology Unit
Merksem, Belgium
Single Ascending Dose (SAD): Number of Participants with Adverse Events
An adverse event 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 Day 14
Multiple Ascending Dose (MAD): Number of Participants with Adverse Events
An adverse event 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 Day 24
SAD: Maximum Observed Plasma Concentration (Cmax)
Cmax is the maximum observed plasma JNJ-64264681 concentration.
Time frame: Up to Day 4
MAD: Maximum Observed Plasma Concentration (Cmax)
Cmax is the maximum observed plasma JNJ-64264681 concentration.
Time frame: Up to Day 13
SAD: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tmax is defined as actual sampling time to reach maximum observed concentration.
Time frame: Up to Day 4
MAD: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Tmax is defined as actual sampling time to reach maximum observed concentration.
Time frame: Up to Day 13
SAD: Time to Last Quantifiable Plasma Concentration (Tlast)
The Tlast is the time to last observed quantifiable plasma concentration.
Time frame: Up to Day 4
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MAD: Time to Last Quantifiable Plasma Concentration (Tlast)
The Tlast is the time to last observed quantifiable plasma concentration.
Time frame: Up to Day 13
SAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24])
AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
Time frame: Day 1: Up to 24 hours post-dose
MAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24])
AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
Time frame: Day 1: Up to 24 hours post-dose
SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUClast)
AUClast is defined as area under the plasma JNJ-64264681 concentration-time curve from time 0 to time of the last observed quantifiable concentration.
Time frame: Up to Day 4
MAD: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)
AUCtau is area under the plasma JNJ-64264681 concentration-time curve during a dosing interval (tau) at steady-state.
Time frame: Day 10
SAD: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
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(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Time frame: Up to Day 3
SAD: Apparent Elimination Half-life (t1/2)
t1/2 is apparent elimination half-life of JNJ-64264681 associated with the terminal slope (z) of the semi-logarithmic drug concentration-time curve.
Time frame: Up to Day 3
MAD: Apparent Elimination Half-life (t1/2)
t1/2 is apparent elimination half-life of JNJ-64264681 associated with the terminal slope (z) of the semi-logarithmic drug concentration-time curve.
Time frame: Up to Day 13
MAD: Accumulation Ratio
MAD: Accumulation Ratio obtained by dividing AUC of JNJ-64264681 at two different time points.
Time frame: Up to Day 13