The purpose of this study is to characterize the pharmacokinetic (PK) of multiple twice-daily doses of JNJ-70033093 in healthy participants and to assess the effects of dosing time and food on the PK of single-dose of JNJ-70033093 in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
JNJ-70033093 capsules will be administered orally .
Matching placebo in capsule will be administered orally.
PRA Health Sciences
Salt Lake City, Utah, United States
Part 1: Maximum Observed Analyte Concentration (Cmax) of JNJ-70033093
Cmax is the maximum observed analyte concentration.
Time frame: Up to Day 9
Part 1: Time to Reach the Maximum Observed Analyte Concentration (Tmax) of JNJ-70033093
Tmax is the actual sampling time to reach the maximum observed analyte concentration
Time frame: Up to Day 9
Part 1: Area Under the Analyte Concentration-time Curve from Time Zero to 12 Hours (AUC[0-12h]) of JNJ-70033093
AUC(0-12h) is the area under the time-concentration curve (AUC) from time 0 (dosing time) to 12 hours before steady state.
Time frame: 12 hours postdose (Day 1)
Part 1: Apparent Terminal Elimination Half-life (t[1/2]) of JNJ-70033093
T(1/2) is the apparent terminal elimination half-life is the time measured for the analyte 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 is calculated as 0.693/lambda(z).
Time frame: Up to Day 9
Part 2: Maximum Observed Analyte Concentration (Cmax) of JNJ-70033093
Cmax is the maximum observed analyte concentration.
Time frame: Up to Day 9
Part 2: Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ-70033093
AUC (0-last) is area under the analyte concentration-time curve (AUC) from time 0 to time of the last quantifiable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.
Time frame: Up to Day 9
Part 2: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-70033093
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AUC (0-infinity) is the area under the analyte concentration-time curve (AUC) from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable (non-BQL) analyte concentration; and lambda(z) is apparent terminal elimination rate constant.
Time frame: Up to Day 9
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 medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment.
Time frame: Up to 51 days
Number of Participants with Vital Sign Abnormalities
Number of participants with vital signs (including body temperature, resting \[supine\] pulse rate, and blood pressure) abnormalities will be reported.
Time frame: Up to 51 days
Number of Participants with Abnormal Electrocardiogram (ECG) Findings
Number of participants with abnormal ECG findings will be reported.
Time frame: Up to 51 days
Number of Participants with Abnormal Laboratory Findings
Number of participants with abnormal laboratory findings (that is, hematology, coagulation tests, clinical chemistry, urinalysis) will be reported.
Time frame: Up to 51 days
Relationship Between JNJ-70033093 Plasma Concentrations and QTc After Multiple Doses of JNJ-70033093
Relationship between JNJ-70033093 plasma concentrations and QTc in healthy participants receiving multiple doses of JNJ-70033093 will be assessed.
Time frame: Up to Day 9
Percentage Change from Baseline in Activated Partial Thromboplastin Time (aPTT)
aPTT measures the time to clot formation via the contact and common activation pathway. Blood will be collected for measurement of changes in aPTT clotting time.
Time frame: Baseline up to Day 9 (Part 1); Baseline up to Day 11 (Part 2)
Percentage Change from Baseline in Factor XI Clotting Activity
Percentage change from baseline in FXI clotting activity will be measured using a modified aPTT assay.
Time frame: Baseline up to Day 9 (Part 1); Baseline up to Day 11 (Part 2)