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| ID | Type | Description | Link |
|---|---|---|---|
| 53718678RSV1004 | Other Identifier | Janssen Sciences Ireland UC | |
| 2014-005410-36 | EudraCT Number |
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The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of three dosages (250, 500, and 1000 milligram [mg], or maximum tolerated dose [MTD]) of JNJ 53718678 when administered as single dose in fasting conditions in healthy Japanese adult participants in 3 cohorts.
This is a Phase 1, single center, double-blind (study in which neither the researchers nor the participants know what treatment the participants are receiving), placebo-controlled (study in which the experimental treatment or procedure is compared to placebo treatment), randomized (study medication assigned to participants by chance) study in healthy Japanese adult participants residing outside of Japan. The study will consist of a Screening phase, an In-clinic treatment phase, and a follow-up phase. The study duration for each participant will be approximately 6 weeks from Screening (Day -28 to Day -2) to follow up visit (Day 10 to 14). Participants will be randomly assign to receive JNJ 53718678 or placebo, at planned dose of 250, 500 and 1000 milligram (mg). Planned doses will be stepwise escalated, if the safety and tolerability of the preceding dose(s) are found to be acceptable, and the maximum tolerated dose (MTD) is not reached. De-escalation may be performed in order to study an intermediate dose. The safety, tolerability and pharmacokinetic (PK) profile of JNJ-53718678 will primarily be evaluated. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ 53718678 250 milligram (mg) | Experimental | Participants will receive either single oral dose of 250 mg of JNJ 53718678 or matching placebo on Day 1. |
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| JNJ 53718678 500 mg | Experimental | Participants will receive either single oral dose of 500 mg of JNJ 53718678 or matching placebo on Day 1. |
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| JNJ 53718678 1000 mg | Experimental | Participants will receive either single oral dose of 1000 mg of JNJ 53718678 or matching placebo on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ 53718678 | Drug | JNJ 53718678 will be orally administered once in a dose of 250, 500 or 1000 mg on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | The Cmax is the maximum observed plasma concentration. | Up to 72 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | The Tmax is defined as actual sampling time to reach maximum observed JNJ 53718678 concentration. | Up to 72 hours post dose |
| Time to Last Quantifiable Plasma Concentration (Tlast) | The Tlast is the time to last observed quantifiable plasma concentration. | Up to 72 hours post dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) | The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time. | Up to 72 hours post dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) | 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, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. | Up to 72 hours post dose |
| Apparent Initial Elimination Rate Constant (lambda [alpha]) | Apparent initial elimination rate constant, determined by linear regression of the data points within the first elimination phase of the ln-linear plasma concentration-time curve. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Sciences Ireland UC Clinical Trials | Janssen Sciences Ireland UC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harrow | United Kingdom |
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| ID | Term |
|---|---|
| C000624632 | JNJ-53718678 |
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| Placebo | Drug | Placebo matching to JNJ 53718678 will be orally administered once on Day 1. |
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| Up to 72 hours post dose |
| Elimination Rate Constant (Lambda[z]) | Lambda(z) is first-order elimination 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. | Up to 72 hours post dose |
| Apparent Initial Elimination Half-life (t1/2[alpha]) | Apparent initial elimination half-life is calculated as 0.693/lambda(alpha). | Up to 72 hours post dose |
| Elimination Half-Life (t1/2) | The elimination half-life (t1/2) is the time measured for the plasma 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). | Up to 72 hours post dose |
| Total Apparent Clearance (CL/F) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Up to 72 hours post dose |
| Apparent Volume of Distribution (Vd/F) | 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 plasma concentration of a drug. Apparent volume of distribution after subcutaneous dose (Vd/F) is influenced by the fraction absorbed. | Up to 72 hours post dose |
| Number of Participants With Adverse Events | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | From sign of informed consent up to end of study (Day 14) |