A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42721458 in Healthy Male Participants

Healthy Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single- and Multiple-Doses of JNJ-42721458 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01840501
• Other study ID #: CR101337
• Secondary ID: 42721458EDI10012
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2013
• Last updated: May 5, 2014
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Directorate general for the protection of Public health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the body does to the medication), potential immunogenicity (ability to induce an immune response), and pharmacodynamics (what the drug does to the body) after administration of JNJ-42721458 in healthy adult male participants.

Description:

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study), single-ascending (increasing) dose and multiple-ascending dose study of JNJ-42721458 compound in healthy males. The study is divided in two parts. Part 1 is a single-ascending dose (SAD) study which will include up to 10 panels (using ascending doses starting from 0.1 mg) in which a single dose of the study medication will be administered on Day 1. Part 2 is a multiple-ascending dose (MAD) study which will include approximately 6 panels (using ascending doses starting from 5.0 mg) in which multiple doses of study medication will be administered once daily for 10 days.

Part 2 will be initiated after completion of dosing and all relevant evaluations from Part

1. In each panel of Part 1 and 2, 6 participants will be randomly assigned to receive JNJ-42721458 and 2 participants randomly assigned to placebo. Safety evaluations will include assessment of adverse events, physical examinations, laboratory tests, vital signs, electrocardiograms, cardiac telemetry and evaluation of injection sites which will be monitored throughout the study. The total study duration for each participant will be approximately 6-7 weeks in Part 1 and 7-8 weeks for each participant in Part 2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body mass index (weight kg/m2) between 18 and 30 kg/m2, and body weight not less than 50 kg

• Participant is judged to be generally in good health based on medical history, physical examination, vital signs and laboratory safety tests

• Blood pressure between 90 and 135 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic

• A 12-lead electrocardiogram consistent with normal cardiac conduction and function

Exclusion Criteria:

• History of or current clinically significant medical illness

• Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or on Day -1 (at admission to the study center)

• Estimated creatinine clearance of less than or equal to 80 mL/min

• Clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram at screening or on Day -1

• Participant demonstrates orthostatic change in vital signs measurements on screening or predose while going from a semi recumbent to standing position

• History of significant multiple and/or severe allergies (including latex allergies) or known history of clinically significant allergies to polyethylene glycol (PEG) containing or other PEGylated products

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-42721458 (single dose)
JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.
• JNJ-42721458 (multiple doses)
JNJ-42721458 will be administered subcutaneously (an injection under the skin) once daily, starting with a dose of 5.0 mg.
• Placebo (single dose)
Matching placebo will be administered subcutaneously (an injection under the skin) as a single dose in Part 1.
• Placebo (multiple doses)
Matching placebo will be administered subcutaneously (an injection under the skin) once daily for 10 days in Part 2.

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	Part 1 and 2: Number of participants with adverse events	Number of participants with adverse events will be used as a measure of safety and tolerability.	Up to 17 weeks	Yes
Primary	Part 1 and 2: Maximum observed concentration (Cmax) of JNJ-42721458		Up to Day 10 (for Part 1) and Day 27 (for Part 2)	No
Primary	Part 1 and 2: Time to reach the maximum plasma concentration (tmax) of JNJ-42721458		Up to Day 10 (for Part 1) and Day 27 (for Part 2)	No
Primary	Part 1 and 2: Area under the concentration-time curve of JNJ-42721458, from time 0 to infinity, with extrapolation of the terminal phase		Up to Day 10 (for Part 1) and Day 27 (for Part 2)	No
Primary	Part 1 and 2: Area under the concentration-time curve of JNJ-42721458 during a dosing interval at steady state		Up to Day 10 (for Part 1) and Day 27 (for Part 2)	No
Primary	Part 1 and 2: Terminal half-life (t1/2) of JNJ-42721458		Up to Day 10 (for Part 1) and Day 27 (for Part 2)	No
Primary	Part 1 and 2: Apparent systemic clearance of drug after subcutaneous administration of JNJ-42721458		Up to Day 10 (for Part 1) and Day 27 (for Part 2)	No
Primary	Part 1 and 2: Apparent volume of distribution after subcutaneous administration of JNJ-42721458		Up to Day 10 (for Part 1) and Day 27 (for Part 2)	No
Primary	Part 1 and 2: Plasma levels of antibodies to JNJ-42721458 for evaluation of potential immunogenicity		Up to Day 10 (for Part 1) and Day 27 (for Part 2)	No
Secondary	Part 1 and 2: Change from baseline in resting heart rate		Up to Day 10 (for Part 1) and Day 27 (for Part 2)	No
Secondary	Part 1 and 2: Change from baseline in resting peripheral blood pressure		Up to Day 10 (for Part 1) and Day 27 (for Part 2)	No