Safety, Tolerability and Pharmacodynamic Activity of JNJ-26528398 in Healthy Male Participants
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|ClinicalTrials.gov Identifier: NCT01520142|
Recruitment Status : Completed
First Posted : January 27, 2012
Last Update Posted : June 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Healthy Participants||Drug: JNJ-26528398 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
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||
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.
- The TNF-α concentrations in plasma (Part 2) [ Time Frame: Days 7-8 ]
- 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 ]
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
|Study Director:||Janssen Research & Development, LLC and Development, L.L.C. Clinical Trial||Janssen Research & Development, LLC|