PRA Health Sciences
Salt Lake City, Utah, 84124, United States
NCT Number: NCT04223349
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Salt Lake City, Utah, 84124, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-70033093 capsules will be administered orally .
Matching placebo in capsule will be administered orally.
Time frame: Up to Day 9
Cmax is the maximum observed analyte concentration.
Time frame: Up to Day 9
Tmax is the actual sampling time to reach the maximum observed analyte concentration
Time frame: 12 hours postdose (Day 1)
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: Up to Day 9
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
Cmax is the maximum observed analyte concentration.
Time frame: Up to Day 9
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
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 51 days
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 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 ECG findings will be reported.
Time frame: Up to 51 days
Number of participants with abnormal laboratory findings (that is, hematology, coagulation tests, clinical chemistry, urinalysis) will be reported.
Time frame: Up to Day 9
Relationship between JNJ-70033093 plasma concentrations and QTc in healthy participants receiving multiple doses of JNJ-70033093 will be assessed.
Time frame: Baseline up to Day 9 (Part 1); Baseline up to Day 11 (Part 2)
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 FXI clotting activity will be measured using a modified aPTT assay.
Janssen Research & Development, LLC
Industry
A Phase 1, Open-label Single-dose Crossover, and Double-blind Multiple-dose Parallel Group Study to Characterize the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of JNJ-70033093 in Healthy Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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