A Phase 1 interventional study of JNJ-63623872 in Healthy, sponsored by Janssen Cilag N.V./S.A.. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by Janssen Cilag N.V./S.A. · Phase 1, Interventional, and Treatment
The primary objective of this study is to characterize the absorption and metabolic pathways of JNJ-63623872, and the excretion of the compound and its metabolites, after single oral dosing of 14C-JNJ-63623872 in healthy adult male participants.
This is a Phase 1, open-label (all people know the identity of the intervention), single dose study in 6 healthy adult male participants to characterize the absorption, metabolism and excretion of 14C-JNJ-63623872. The total study duration will be approximately of 16 days per participant. The study consists of 3 parts: Screening (that is, 28 days before study commences on Day 1); open-Label Treatment Phase(that is, Day 1); and Follow-up (that is, up to Day 16). All the eligible participants will receive 14C-JNJ-63623872 at a dose level of 600 milligram. Participants will enter the study site on Day -1 and stay at the study site at least until Day 8. Urine, feces, whole blood samples, plasma, nasal mucus and saliva samples will be collected up to Day 8. Unchanged JNJ-63623872 will be determined in plasma and, if feasible, in saliva. Participants' safety will be monitored throughout the study.
Janssen Cilag N.V./S.A. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a single 600-milligram (mg) dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872.
Drug: JNJ-63623872
Participants will receive a single 600-mg dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872.
Also known as: 14C-JNJ-63623872
Maximum Plasma Concentration (Cmax) of JNJ-63623872
The Cmax is the maximum plasma concentration.
Time frame: Baseline up to Day 8
Time to reach maximum concentration (tmax) of JNJ-63623872
The Tmax is time to reach the maximum plasma concentration.
Time frame: Baseline up to Day 8
Area Under the Plasma Concentration-Time Curve From Time Zero to Last (AUC [0-last]) of JNJ-63623872
AUC from time 0 to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.
Time frame: Baseline up to Day 8
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-63623872
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; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Time frame: Baseline up to Day 8
Terminal Half-Life(t[1/2]) of JNJ-63623872
Terminal half-life (t\[(1/2\]) is defined as 0.693/Lambda(z).
Time frame: Baseline up to Day 8
Rate Constant (Lambda[z])
Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Time frame: Baseline up to Day 8
Apparent total body clearance (CL/F) of JNJ-63623872
Clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The CL/F will be calculated by dividing the dose by AUC (0-infinity).
Time frame: Baseline up to Day 8
Apparent volume of distribution at the terminal Phase (Vd[z] /F) of JNJ-63623872
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.The Vd(z)/F will be calculated by dividing CL/F by lambda(z).
Time frame: Baseline up to Day 8
Amount of JNJ-63623872 excreted in Urine (Ae[x-y])
Amount excreted into urine over a given time interval, calculated from the urinary drug concentration of the collection interval x to y hours post dosing multiplied with the associated urine volume of the interval.
Time frame: Baseline up to Day 8
Total Amount of JNJ-63623872 excreted in Urine (Ae[total])
Total amount excreted into urine, calculated by adding the amounts of the individual intervals together.
Time frame: Baseline up to Day 8
Percentage of JNJ-63623872 dose excreted into urine
Percentage of the dose excreted into urine of the collection interval x to y hours post dosing, calculated as 100 x (Aex-y/Dose).
Time frame: Baseline up to Day 8
Total Percentage of JNJ-63623872 dose excreted into urine
Total percentage of the dose excreted into urine, calculated as 100 \* (Ae\[total\]/Dose).
Time frame: Baseline up to Day 8
Renal clearance
Renal clearance calculated as Ae (total)/AUC (infinity).
Time frame: Baseline up to Day 8
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Janssen Cilag N.V./S.A.