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

NCT ID: NCT01840501

Last Updated: 2014-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-04-30

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part 1: Panel 1 (0.1 mg JNJ-42721458)

6 participants will receive a single dose of 0.1 mg of JNJ-42721458.

Group Type: EXPERIMENTAL

JNJ-42721458 (single dose)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Part 1: Panel 2 (0.3 mg JNJ-42721458)

6 participants will receive a single dose of 0.3 mg of JNJ-42721458.

Group Type: EXPERIMENTAL

JNJ-42721458 (single dose)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Part 1: Panel 3 (1.0 mg JNJ-42721458)

6 participants will receive a single dose of 1.0 mg of JNJ-42721458.

Group Type: EXPERIMENTAL

JNJ-42721458 (single dose)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Part 1: Panel 4 (2.5 mg JNJ-42721458)

6 participants will receive a single dose of 2.5 mg of JNJ-42721458.

Group Type: EXPERIMENTAL

JNJ-42721458 (single dose)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Part 1: Panel 5 (5.0 mg JNJ-42721458)

6 participants will receive a single dose of 5.0 mg of JNJ-42721458.

Group Type: EXPERIMENTAL

JNJ-42721458 (single dose)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Part 1: Panel 6 (10.0 mg JNJ-42721458)

6 participants will receive a single dose of 10.0 mg of JNJ-42721458.

Group Type: EXPERIMENTAL

JNJ-42721458 (single dose)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Part 1: Panel 7 (20.0 mg JNJ-42721458)

6 participants will receive a single dose of 20.0 mg of JNJ-42721458.

Group Type: EXPERIMENTAL

JNJ-42721458 (single dose)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

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.

Group Type: EXPERIMENTAL

JNJ-42721458 (single dose)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

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.

Group Type: EXPERIMENTAL

JNJ-42721458 (single dose)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

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.

Group Type: EXPERIMENTAL

JNJ-42721458 (single dose)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Part 1: Placebo

2 participants from each panel will receive a single dose of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo (single dose)

Intervention Type: DRUG

Matching placebo will be administered subcutaneously (an injection under the skin) as a single dose in Part 1.

Part 2: Panel 1 (5.0 mg JNJ-42721458)

6 participants will receive multiple doses of 5.0 mg of JNJ-42721458.

Group Type: EXPERIMENTAL

JNJ-42721458 (multiple doses)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) once daily, starting with a dose of 5.0 mg.

Part 2: Panel 2 (10.0 mg JNJ-42721458)

6 participants will receive multiple doses of 10.0 mg of JNJ-42721458.

Group Type: EXPERIMENTAL

JNJ-42721458 (multiple doses)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) once daily, starting with a dose of 5.0 mg.

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.

Group Type: EXPERIMENTAL

JNJ-42721458 (multiple doses)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) once daily, starting with a dose of 5.0 mg.

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.

Group Type: EXPERIMENTAL

JNJ-42721458 (multiple doses)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) once daily, starting with a dose of 5.0 mg.

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.

Group Type: EXPERIMENTAL

JNJ-42721458 (multiple doses)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) once daily, starting with a dose of 5.0 mg.

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.

Group Type: EXPERIMENTAL

JNJ-42721458 (multiple doses)

Intervention Type: DRUG

JNJ-42721458 will be administered subcutaneously (an injection under the skin) once daily, starting with a dose of 5.0 mg.

Part 2: Placebo

2 participants from each panel will receive multiple doses of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo (multiple doses)

Intervention Type: DRUG

Matching placebo will be administered subcutaneously (an injection under the skin) once daily for 10 days in Part 2.

Interventions

JNJ-42721458 (single dose)

JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.

Intervention Type: 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.

Intervention Type: DRUG

Placebo (single dose)

Matching placebo will be administered subcutaneously (an injection under the skin) as a single dose in Part 1.

Intervention Type: DRUG

Placebo (multiple doses)

Matching placebo will be administered subcutaneously (an injection under the skin) once daily for 10 days in Part 2.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Merksem, , Belgium

Countries

Belgium

Other Identifiers

42721458EDI1001

Identifier Type: OTHER

Identifier Source: secondary_id

2013-000557-47

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR101337

Identifier Type: -

Identifier Source: org_study_id