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

NCT01840501 | Completed Phase 1

• 3 other identifiers: CR10133742721458EDI10012013-000557-47
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; JNJ-42721458; Male; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; Immunogenicity

Outcome Measures

Primary Outcomes (9)

• 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

• Part 1 and 2: Maximum observed concentration (Cmax) of JNJ-42721458

  Up to Day 10 (for Part 1) and Day 27 (for Part 2)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Secondary Outcomes (2)

• Part 1 and 2: Change from baseline in resting heart rate

  Up to Day 10 (for Part 1) and Day 27 (for Part 2)

• 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)

Study Arms (18)

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

EXPERIMENTAL

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

Drug: JNJ-42721458 (single dose)

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

EXPERIMENTAL

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

Drug: JNJ-42721458 (single dose)

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

EXPERIMENTAL

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

Drug: JNJ-42721458 (single dose)

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

EXPERIMENTAL

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

Drug: JNJ-42721458 (single dose)

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

EXPERIMENTAL

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

Drug: JNJ-42721458 (single dose)

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

EXPERIMENTAL

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

Drug: JNJ-42721458 (single dose)

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

EXPERIMENTAL

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

Drug: JNJ-42721458 (single dose)

Part 1: Panel 8

EXPERIMENTAL

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)

Part 1: Panel 9

EXPERIMENTAL

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)

Part 1: Panel 10

EXPERIMENTAL

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)

Part 1: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (single dose)

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

EXPERIMENTAL

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

Drug: JNJ-42721458 (multiple doses)

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

EXPERIMENTAL

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

Drug: JNJ-42721458 (multiple doses)

Part 2: Panel 3

EXPERIMENTAL

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)

Part 2: Panel 4

EXPERIMENTAL

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)

Part 2: Panel 5

EXPERIMENTAL

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)

Part 2: Panel 6

EXPERIMENTAL

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)

Part 2: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (multiple doses)

Interventions

JNJ-42721458 (single dose) DRUG

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

Part 1: Panel 1 (0.1 mg JNJ-42721458); Part 1: Panel 10; Part 1: Panel 2 (0.3 mg JNJ-42721458); Part 1: Panel 3 (1.0 mg JNJ-42721458); Part 1: Panel 4 (2.5 mg JNJ-42721458); Part 1: Panel 5 (5.0 mg JNJ-42721458); Part 1: Panel 6 (10.0 mg JNJ-42721458); Part 1: Panel 7 (20.0 mg JNJ-42721458); Part 1: Panel 8; Part 1: Panel 9

JNJ-42721458 (multiple doses) 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 1 (5.0 mg JNJ-42721458); Part 2: Panel 2 (10.0 mg JNJ-42721458); Part 2: Panel 3; Part 2: Panel 4; Part 2: Panel 5; Part 2: Panel 6

Placebo (single dose) DRUG

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

Part 1: Placebo

Placebo (multiple doses) DRUG

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

Part 2: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 25, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

BE (1)