Safety, Tolerability and Pharmacodynamic Activity of JNJ-26528398 in Healthy Male Participants

NCT01520142 | Completed Phase 1

• 3 other identifiers: CR10075426528398EDI10012011-004459-38
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the anti-inflammatory properties of JNJ-26528398 using an intravenous (IV) endotoxin-induced model of acute, transient inflammation.

Conditions

Healthy Participants

Keywords

Healthy participants; Pharmacodynamic; Pharmacokinetics; Intravenous Endotoxin-Induced Model; Acute Inflammation; JNJ-26528398; Anti-inflammatory

Outcome Measures

Primary Outcomes (1)

• The TNF-α concentrations in plasma (Part 2)

  Days 7-8

Secondary Outcomes (5)

• Other markers of inflammation in blood (Part 2)

  Days 7-8

• Profile of Mood States (POMS) (Part 2)

  Days 1 and 7

• Incidence of adverse events amongst participants (Parts 1 and 2)

  Days -1 to 10 and Day 24

• Area under the curve (AUC) of JNJ-26528398 (Parts 1 and 2)

  Days 1-10

• Maximum plasma concentration (Cmax) of JNJ-26528398 (Parts 1 and 2)

  Days 1-10

Study Arms (2)

Treatment

EXPERIMENTAL

Drug: JNJ-26528398

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JNJ-26528398 DRUG

In Study Part 1, the participant will receive an oral solution of JNJ-26528398 3 mg once daily for 7 days. The same dosing regimen is planned for Part 2, but may be adjusted (lower dose and/or fewer dosing days) based on the data from Part 1.

Treatment

Placebo DRUG

In both Study Part 1 and Part 2, the participant will receive an oral solution of matching placebo once daily for up to 7 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Nonsmoker
• Be in good health on the basis of physical examination, medical history, and electrocardiogram (ECG)
• Must have good exercise tolerance
• Have a body mass index of 18-29 kg/m2, inclusive, and body weight between 60 and 85 kg, inclusive
• Have a history of consistent dental hygiene and dental care
• Must adhere to required contraception (subject and partner, if applicable) during the study and for 3 months after study
• Must agree to not donate sperm during the study and for 3 months after study

You may not qualify if:

• Is currently enrolled in an investigational study, has recently received an investigational drug (including investigational vaccines), or has donated blood within 3 months
• Has had a vaccination within past 3 months
• Has history of significant drug or alcohol abuse within past 2 years or has a positive drug screen
• Blood donation within past 3 months
• Part 2 only: Has received endotoxin within past 3 months, or has a known allergy or history of significant adverse reaction to endotoxin or its excipients lactose and polyethylene glycol 6000

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

Study Officials

• Janssen Research & Development, LLC and Development, L.L.C. 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: December 9, 2011
• First Posted: January 27, 2012
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 24, 2013

Record last verified: 2013-06

Locations

BE (1)