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

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ClinicalTrials.gov Identifier: NCT01840501
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : May 6, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-42721458 (single dose) Drug: JNJ-42721458 (multiple doses) Drug: Placebo (single dose) Drug: Placebo (multiple doses) Phase 1

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : April 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: Part 1: Panel 1 (0.1 mg JNJ-42721458)
6 participants will receive a single dose of 0.1 mg of JNJ-42721458.
Drug: JNJ-42721458 (single dose)
JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Experimental: Part 1: Panel 2 (0.3 mg JNJ-42721458)
6 participants will receive a single dose of 0.3 mg of JNJ-42721458.
Drug: JNJ-42721458 (single dose)
JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Experimental: Part 1: Panel 3 (1.0 mg JNJ-42721458)
6 participants will receive a single dose of 1.0 mg of JNJ-42721458.
Drug: JNJ-42721458 (single dose)
JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Experimental: Part 1: Panel 4 (2.5 mg JNJ-42721458)
6 participants will receive a single dose of 2.5 mg of JNJ-42721458.
Drug: JNJ-42721458 (single dose)
JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Experimental: Part 1: Panel 5 (5.0 mg JNJ-42721458)
6 participants will receive a single dose of 5.0 mg of JNJ-42721458.
Drug: JNJ-42721458 (single dose)
JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Experimental: Part 1: Panel 6 (10.0 mg JNJ-42721458)
6 participants will receive a single dose of 10.0 mg of JNJ-42721458.
Drug: JNJ-42721458 (single dose)
JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Experimental: Part 1: Panel 7 (20.0 mg JNJ-42721458)
6 participants will receive a single dose of 20.0 mg of JNJ-42721458.
Drug: JNJ-42721458 (single dose)
JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Experimental: Part 1: Panel 8
6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-7 in Part 1.
Drug: JNJ-42721458 (single dose)
JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Experimental: Part 1: Panel 9
6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-8 in Part 1.
Drug: JNJ-42721458 (single dose)
JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Experimental: Part 1: Panel 10
6 participants will receive a single dose JNJ-42721458, the dose will be determined after completion of panels 1-9 in Part 1.
Drug: JNJ-42721458 (single dose)
JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Placebo Comparator: Part 1: Placebo
2 participants from each panel will receive a single dose of placebo.
Drug: Placebo (single dose)
Matching placebo will be administered subcutaneously (an injection under the skin) as a single dose in Part 1.

Experimental: Part 2: Panel 1 (5.0 mg JNJ-42721458)
6 participants will receive multiple doses of 5.0 mg of JNJ-42721458.
Drug: 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.

Experimental: Part 2: Panel 2 (10.0 mg JNJ-42721458)
6 participants will receive multiple doses of 10.0 mg of JNJ-42721458.
Drug: 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.

Experimental: Part 2: Panel 3
6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-2 in Part 2.
Drug: 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.

Experimental: Part 2: Panel 4
6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-3 in Part 2.
Drug: 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.

Experimental: Part 2: Panel 5
6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-4 in Part 2.
Drug: 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.

Experimental: Part 2: Panel 6
6 participants will receive multiple doses of JNJ-42721458, the dose will be determined after completion of panels 1-5 in Part 2.
Drug: 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 Comparator: Part 2: Placebo
2 participants from each panel will receive multiple doses of placebo.
Drug: Placebo (multiple doses)
Matching placebo will be administered subcutaneously (an injection under the skin) once daily for 10 days in Part 2.




Primary Outcome Measures :
  1. Part 1 and 2: Number of participants with adverse events [ Time Frame: Up to 17 weeks ]
    Number of participants with adverse events will be used as a measure of safety and tolerability.

  2. Part 1 and 2: Maximum observed concentration (Cmax) of JNJ-42721458 [ Time Frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2) ]
  3. Part 1 and 2: Time to reach the maximum plasma concentration (tmax) of JNJ-42721458 [ Time Frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2) ]
  4. Part 1 and 2: Area under the concentration-time curve of JNJ-42721458, from time 0 to infinity, with extrapolation of the terminal phase [ Time Frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2) ]
  5. Part 1 and 2: Area under the concentration-time curve of JNJ-42721458 during a dosing interval at steady state [ Time Frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2) ]
  6. Part 1 and 2: Terminal half-life (t1/2) of JNJ-42721458 [ Time Frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2) ]
  7. Part 1 and 2: Apparent systemic clearance of drug after subcutaneous administration of JNJ-42721458 [ Time Frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2) ]
  8. Part 1 and 2: Apparent volume of distribution after subcutaneous administration of JNJ-42721458 [ Time Frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2) ]
  9. Part 1 and 2: Plasma levels of antibodies to JNJ-42721458 for evaluation of potential immunogenicity [ Time Frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2) ]

Secondary Outcome Measures :
  1. Part 1 and 2: Change from baseline in resting heart rate [ Time Frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2) ]
  2. Part 1 and 2: Change from baseline in resting peripheral blood pressure [ Time Frame: Up to Day 10 (for Part 1) and Day 27 (for Part 2) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840501


Locations
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Belgium
Merksem, Belgium
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01840501     History of Changes
Other Study ID Numbers: CR101337
42721458EDI1001 ( Other Identifier: Janssen Research & Development, LLC )
2013-000557-47 ( EudraCT Number )
First Posted: April 25, 2013    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014
Keywords provided by Janssen Research & Development, LLC:
Healthy
JNJ-42721458
Male
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
Immunogenicity