A Safety, Tolerability and Pharmacokinetics Study of a Single Intravenous Dose of JNJ-49122944 in Healthy Male Participants

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of JNJ-49122944 in healthy male participants after a single intravenous ([IV] within a vein) dose administration.

Detailed Description
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This is a double-blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study drug assigned by chance), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), and single-center study. The study will consist of Screening Period (2 to 21 days prior to participants' dose administration), Double-blind Treatment Period (single dose of JNJ-49122944 or placebo on Day 1), and Safety Follow-up Period (4 to 7 days after discharge). The total duration of participation for each participant, including screening, will be up to approximately 4 weeks. Blood samples will be collected for assessment of pharmacokinetic parameters. Participants' safety will be monitored throughout the study.

Official Title
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A Double Blind, Placebo-Controlled, Randomized Study to Investigate the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Dose of JNJ-49122944 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: JNJ-49122944, 5 milligram (mg)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male participant, aged 18 to 55 inclusive Participant must have a body Mass Index (BMI) between 18 and 30 kilogram per square meter (kg/m^2), inclusive, and body weight not less than 50 kg Participant must be deemed healthy on the basis of physical examination, medical history, laboratory tests, vital signs, and 12-lead electrocardiogram within protocol-defined parameters performed at screening and Day -1 Participant agrees to protocol-defined use of effective contraception Participant should be non-nicotine user for 6 months prior to screening Exclusion Criteria: Participants with current or history of clinically significant medical illness Participants with history of drug or alcohol abuse within 5 years Routine consumption of greater than 450 milligram (mg) of caffeine per day by the participant Participants with recent vaccination or acute illness Blood donation or major blood loss within 3 months prior to study drug administration by the participant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JNJ-49122944, 5 milligram (mg)<br>Single dose of 5 mg JNJ-49122944, administered as a 22.2 milliliter (mL) intravenous (IV) infusion over 45 minutes in the morning following an overnight fast. | Drug: JNJ-49122944, 5 milligram (mg)<br>* Participants will receive single dose of 5 mg JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.<br>|
| Placebo Comparator: Placebo<br>Placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes in the morning following an overnight fast. | Drug: Placebo<br>* Participants will receive placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Throughout the duration of study (up to 4 weeks) | 
| Maximum Plasma Concentration (Cmax) of JNJ-49122944 | The Cmax is the maximum observed plasma concentration during dosing interval. | Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3 | 
| Area Under the Plasma Concentration Time Curve From Time 0 to Last Quantifiable Time (AUClast) of JNJ-49122944 | The AUC(last) is the area under the plasma concentration time curve from time 0 to the time corresponding to the last quantifiable plasma concentration. | Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3 | 
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-49122944 | 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. | Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3 | 
| Percentage of Area Under the Plasma Concentration-time Curve Obtained by Extrapolation (%AUC [infinity,ex]) of JNJ-49122944 | Percentage of area under the plasma concentration-time curve obtained by extrapolation (%AUC[inf,ex]) is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100 (AUC[0-infinity] - AUC[0-last])*100/AUC[0-infinity]. | Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3 | 
| Elimination Half-life (t1/2) of JNJ-49122944 | Elimination half-life (t [1/2]) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z). | Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3 | 
| Rate Constant (Lambda[z]) of JNJ-49122944 | 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. | Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3 | 
| Apparent Clearance (CL) of JNJ-49122944 | Apparent clearance of JNJ-49122944 is calculated as Dose/AUC(infinity). The AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time. | Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3 | 
| Apparent Volume of Distribution (Vz) of JNJ-49122944 | Apparent volume of distribution after intravenous administration is calculated as Dose divided by Lambda(z) multiplied by AUC(0-inifinity). | Pre-dose, 0.25, 0.50, 0.75, 1, 1.25, 1.75, 2.75, 4.75, 6.75, 12.75 hour post- dose on Day 1, 24.75 hour post-dose on Day 2, 48.75 hour post-dose on Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, JNJ-49122944, Placebo