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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014