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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520142
• Other study ID #: CR100754
• Secondary ID: 26528398EDI10012
• Status: Completed
• Phase: Phase 1
• First received: December 9, 2011
• Last updated: June 21, 2013
• Start date: November 2011
• Est. completion date: April 2012

Study information

• Verified date: June 2013
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The TNF-a concentrations in plasma (Part 2)		Days 7-8	No
Secondary	Other markers of inflammation in blood (Part 2)		Days 7-8	No
Secondary	Profile of Mood States (POMS) (Part 2)	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).	Days 1 and 7	No
Secondary	Incidence of adverse events amongst participants (Parts 1 and 2)		Days -1 to 10 and Day 24	No
Secondary	Area under the curve (AUC) of JNJ-26528398 (Parts 1 and 2)	Blood concentrations sampled at frequent intervals	Days 1-10	No
Secondary	Maximum plasma concentration (Cmax) of JNJ-26528398 (Parts 1 and 2)		Days 1-10	No