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Completed

NCT Number: NCT02280018

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Merksem, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-49122944, 5 milligram (mg)

Drug

Participants will receive single dose of 5 mg JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.

Placebo

Drug

Participants will receive placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

    Time frame: Throughout the duration of study (up to 4 weeks)

    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.

  2. Maximum Plasma Concentration (Cmax) of JNJ-49122944

    Time frame: 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

    The Cmax is the maximum observed plasma concentration during dosing interval.

  3. Area Under the Plasma Concentration Time Curve From Time 0 to Last Quantifiable Time (AUClast) of JNJ-49122944

    Time frame: 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

    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.

  4. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-49122944

    Time frame: 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

    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.

  5. Percentage of Area Under the Plasma Concentration-time Curve Obtained by Extrapolation (%AUC [infinity,ex]) of JNJ-49122944

    Time frame: 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[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].

  6. Elimination Half-life (t1/2) of JNJ-49122944

    Time frame: 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 (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).

  7. Rate Constant (Lambda[z]) of JNJ-49122944

    Time frame: 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

    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.

  8. Apparent Clearance (CL) of JNJ-49122944

    Time frame: 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 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.

  9. Apparent Volume of Distribution (Vz) of JNJ-49122944

    Time frame: 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 after intravenous administration is calculated as Dose divided by Lambda(z) multiplied by AUC(0-inifinity).

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 31, 2014
Registry last updated
Jan 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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