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| ID | Type | Description | Link |
|---|---|---|---|
| 63623872FLZ1007 | Other Identifier | Janssen Cilag N.V./S.A., Belgium | |
| 2015-000719-42 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-63623872 | Experimental | Participants will receive a single 600-milligram (mg) dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-63623872 | Drug | Participants will receive a single 600-mg dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of JNJ-63623872 | The Cmax is the maximum plasma concentration. | Baseline up to Day 8 |
| Time to reach maximum concentration (tmax) of JNJ-63623872 | The Tmax is time to reach the maximum plasma concentration. | 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. | 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. | 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). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Cilag N.V./S.A., Belgium Clinical Trial | Janssen Cilag N.V./S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groningen | Netherlands |
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| ID | Term |
|---|---|
| C000605010 | pimodivir |
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| 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). | 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). | 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. | 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. | 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). | 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). | Baseline up to Day 8 |
| Renal clearance | Renal clearance calculated as Ae (total)/AUC (infinity). | Baseline up to Day 8 |