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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280018
• Other study ID #: CR105925
• Secondary ID: 49122944EDI10012
• Status: Completed
• Phase: Phase 1
• First received: October 29, 2014
• Last updated: January 29, 2015
• Start date: November 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-49122944, 5 milligram (mg)
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
Participants will receive placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No