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| ID | Type | Description | Link |
|---|---|---|---|
| 63623872FLZ1002 | Other Identifier | Janssen-Cilag International NV | |
| 2016-000921-37 | EudraCT Number |
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The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of single escalating intravenous (IV) doses of JNJ-63623872 administered as a continuous infusion; to evaluate the safety and tolerability of single escalating IV doses of JNJ-63623872 administered as a continuous infusion; to characterize the single-dose PK of JNJ-63623872 of one selected dose administered as a continuous IV infusion at various durations and to characterize the single- and repeat-dose PK of JNJ-63623872 administered as a continuous infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Period 1 (JNJ-63623872 100 mg or Placebo) | Experimental | Participants will receive a single intravenous (IV) infusion of JNJ-63623872 100 milligram (mg) [3 milligram per milliliters (mg/mL) solution] (Treatment A) or matching placebo (Treatment D) over 120 minutes. |
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| Part 1: Period 2 (JNJ-63623872 200 mg or Placebo) | Experimental | Participants will receive a single IV infusion of JNJ-63623872 200 mg (3 mg/mL solution) (Treatment B) or matching placebo (Treatment D) over 120 minutes. |
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| Part 1: Period 3 (JNJ-63623872 300 mg or Placebo) | Experimental | Participants will receive a single IV infusion of JNJ-63623872 300 mg (3 mg/mL solution) (Treatment C) or matching placebo (Treatment D) over 120 minutes. |
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| Part 2: Group 1 (EFG) | Experimental | Participants will receive a single IV 300-mg infusion of JNJ-63623872 (3 mg/mL solution) over x minutes (Treatment E) followed by a single IV 300-mg infusion of JNJ-63623872 (3 mg/mL solution) over y minutes (Treatment F), then a single oral 600-mg dose (2* 300 mg tablets) of JNJ-63623872 under fasted conditions (Treatment G). Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-63623872 | Drug | 3 mg/mL solution as intravenous (IV) infusion or a single oral 600 mg dose (2 tablets of 300 mg) under fasted conditions will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Analyte Concentration (Cmax) | The Cmax is the maximum observed analyte concentration. | Up to 10 days |
| Fluctuation Index (FI) | FI is defined as the percentage fluctuation between the Ctrough, morning analyte concentration and the maximum analyte concentration. | Up to 10 days |
| Average Analyte Concentration (Cavg) | The Cavg is an average analyte concentration at steady-state over the dosing interval. | Up to 10 days |
| Time to Reach the Maximum Observed Analyte Concentration (Tmax) | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Up to 10 days |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to 12 Hour (AUC [0-12]) | The (AUC [0-12]) is the area under the plasma concentration-time curve from time 0 to 12 hour post dose, calculated by linear-linear trapezoidal summation. | Up to 10 days |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC [0-last]) | The (AUC [0-last]) is the area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation. | Up to 10 days |
| Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Bioavailability (F[abs]) | The F(abs) is calculated as AUC (0-infinity), oral/ AUC (0-infinity), intravenous (iv)*Dose, iv/Dose, oral*100 %, where AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of administered drug. | Up to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
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| Part 2: Group 2 (FGE) | Experimental | Participants will receive Treatment F, then Treatment G followed by Treatment E. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. |
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| Part 2: Group 3 (GEF) | Experimental | Participants will receive Treatment G, then Treatment E followed by Treatment F. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. |
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| Part 2: Group 4 (GFE) | Experimental | Participants will receive Treatment G, then Treatment F, followed by Treatment E. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. |
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| Part 2: Group 5 (FEG) | Experimental | Participants will receive Treatment F, then Treatment E followed by Treatment G. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. |
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| Part 2: Group 6 (EGF) | Experimental | Participants will receive Treatment E, then Treatment G followed by Treatment F. Study drug administration in subsequent treatment periods will be separated by a washout period of at least 7 days. |
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| Part 3: JNJ-63623872 300 mg | Experimental | Participants will receive multiple IV infusions of JNJ-63623872 300 mg (3 mg/mL) solution every 12 hours on Days 1 to 10, with only a morning dose on Day 10. Duration of infusion and dose will be selected after Part 2 of this study is completed. |
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| Placebo | Drug | Intravenous infusion of matching placebo. |
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The AUC (0-infinity) is the area under the plasma concentration-time curve from time 0 to infinity, calculated as the sum of AUC(last) and C(last)/lambda(z), where Clast is the last observed measurable (non-BQL) concentration; extrapolations of more than 20.00 percent (%) of the total AUC are reported as approximations. |
| Up to 10 days |
| Elimination Rate Constant (Lambda[z]) | Lambda(z) is apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log transformed concentration-time curve. | Up to 10 days |
| Apparent Terminal Elimination Half-life (t1/2term) | Apparent terminal elimination half-life is defined as 0.693/Lambda[z]. | Up to 10 days |
| Systemic Clearance (CL) | CL is the total systemic clearance, following intravenous administration. | Up to 10 days |
| Apparent Clearance (CL/F) | CL/F is the total apparent clearance, following extravascular administration. | Up to 10 days |
| Volume of Distribution (Vd) | The Vd is defined as volume of distribution, following single dose intravenous administration. | Up to 10 days |
| Apparent Volume of Distribution (Vd/F) | Vd/F is defined as apparent volume of distribution, following single dose extravascular administration. | Up to 10 days |
| Volume of Distribution at Steady-State (Vss) | Vss is defined as apparent volume of distribution at steady-state following intravenous administration. | Up to 10 days |
| Observed Accumulation Index (RA abs) | Observed Accumulation Index is calculated by AUC12h, steady state/(AUC12h, single dose). | Up to 10 days |
| Morning Trough Analyte Concentration (Ctrough, morning) | Ctrough, morning is defined as observed analyte concentration just prior to the beginning of a dosing interval. | Up to 10 days |
| Evening Trough Analyte Concentration (Ctrough, evening) | Ctrough, evening is defined as observed analyte concentration at the end of a dosing interval. | Up to 10 days |
| Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | Up to End of Study (Day 14) |
| ID | Term |
|---|---|
| C000605010 | pimodivir |
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