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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01520142
First Posted: January 27, 2012
Last Update Posted: June 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Other markers of inflammation in blood (Part 2) [ Time Frame: Days 7-8 ]
  • Profile of Mood States (POMS) (Part 2) [ Time Frame: Days 1 and 7 ]
    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 ]
  • Area under the curve (AUC) of JNJ-26528398 (Parts 1 and 2) [ Time Frame: Days 1-10 ]
    Blood concentrations sampled at frequent intervals

  • Maximum plasma concentration (Cmax) of JNJ-26528398 (Parts 1 and 2) [ Time Frame: Days 1-10 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01520142     History of Changes
Other Study ID Numbers: CR100754
26528398EDI1001 ( Other Identifier: Janssen Research & Development, LLC )
2011-004459-38 ( EudraCT Number )
First Submitted: December 9, 2011
First Posted: January 27, 2012
Last Update Posted: June 24, 2013
Last Verified: June 2013

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