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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01520142
First received: December 9, 2011
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Healthy Participants
Drug: JNJ-26528398
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Two-Part, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacodynamic Activity of JNJ-26528398 in Healthy Male Subjects Employing the Intravenous Endotoxin-Induced Model of Acute Inflammation

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • The TNF-α concentrations in plasma (Part 2) [ Time Frame: Days 7-8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other markers of inflammation in blood (Part 2) [ Time Frame: Days 7-8 ] [ Designated as safety issue: No ]
  • Profile of Mood States (POMS) (Part 2) [ Time Frame: Days 1 and 7 ] [ Designated as safety issue: No ]
    The POMS Standard Form contains 65 items and assesses six dimensions of mood: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Each item is rated by the participant using a 5-point scale ranging from 1 (not at all) to 5 (extremely).

  • Incidence of adverse events amongst participants (Parts 1 and 2) [ Time Frame: Days -1 to 10 and Day 24 ] [ Designated as safety issue: No ]
  • Area under the curve (AUC) of JNJ-26528398 (Parts 1 and 2) [ Time Frame: Days 1-10 ] [ Designated as safety issue: No ]
    Blood concentrations sampled at frequent intervals

  • Maximum plasma concentration (Cmax) of JNJ-26528398 (Parts 1 and 2) [ Time Frame: Days 1-10 ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: JNJ-26528398
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.
Placebo Comparator: Placebo Drug: Placebo
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.

Detailed Description:

This is a 2-part, single center, double-blind study (neither physician nor participant knows the treatment that the participant receives). Part 1 is designed to evaluate the safety, tolerability, and pharmacokinetics (level of drug in the blood) of a dosing regimen of an investigational drug (JNJ-26528398) prior to its use in Part 2. In Part 1, participants will be assigned by chance to receive either 3 mg/day JNJ-26528398 (6 participants) or placebo (3 participants) for 7 consecutive days while staying in the clinic for 10 days. Placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. Part 2 is designed to evaluate the anti-inflammatory properties of JNJ-26528398 by measuring markers of inflammation in the blood after intravenous (IV) administration of a substance (endotoxin) which activates the immune system and temporarily causes flu-like symptoms. In Part 2, participants will be assigned by chance to receive up to 3 mg/day JNJ-26528398 (6 participants) or placebo (4 participants) for up to 7 consecutive days while staying in the clinic for 10 days. Endotoxin will be given on the last day of study drug administration. Participants will remain in bed for at least 6 hours after endotoxin administration and will be closely monitored by study personnel.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520142

Locations
Belgium
Antwerp, Belgium
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC and Development, L.L.C. Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01520142     History of Changes
Other Study ID Numbers: CR100754, 26528398EDI1001, 2011-004459-38
Study First Received: December 9, 2011
Last Updated: June 21, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Janssen Research & Development, LLC:
Healthy participants
Pharmacodynamic
Pharmacokinetics
Intravenous Endotoxin-Induced Model
Acute Inflammation
JNJ-26528398
Anti-inflammatory

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014