The purpose of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of a single dose of JNJ-70033093 spray dried dispersion (SDD) tablets compared with JNJ-70033093 SDD granule capsules in healthy participants under fasting conditions in Part 1 and 2 and to assess the effect of food on the bioavailability of a single dose of JNJ-70033093 SDD tablets in Part 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
JNJ-70033093 will be administered orally as per assigned treatment sequence.
Clinical Pharmacology Unit
Merksem, Belgium
Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-70033093
Cmax is defined as maximum observed plasma concentration after administration of JNJ-70033093.
Time frame: Up to 72 hours post dose
Part 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC [0-last]) of JNJ-70033093
AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration after administration of JNJ-70033093.
Time frame: Up to 72 hours post dose
Part 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of JNJ-70033093
AUC (0-inf) is defined as area under the plasma concentration-time curve from time 0 to infinity after administration of JNJ-70033093.
Time frame: Up to 72 hours post dose
Part 1 and 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-70033093
Tmax is defined time to reach the maximum observed plasma concentration.
Time frame: Up to 72 hours post dose
Part 1 and 2: Apparent Elimination Half-life (t1/2) of JNJ-70033093
Apparent elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve.
Time frame: Up to 72 hours post dose
Part 1 and 2: 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 investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
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Time frame: Up to 2 Months
Part 1 and 2: Number of Participants with Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in vital signs including temperature (axillary), pulse rate, respiratory rate, blood pressure will be reported.
Time frame: Up to 2 Months
Part 1 and 2: Number of Participants with Abnormalities in Electrocardiogram (ECG)
Number of participants with abnormalities in ECG will be reported.
Time frame: Up to 2 Months
Part 1 and 2: Number of Participants with Clinically Significant Changes in Physical Examination
Number of participants with clinically significant changes in physical examination including height and body weight will be reported.
Time frame: Up to 2 Months