Safety, Tolerability and Pharmacodynamic Activity of JNJ-26528398 in Healthy Male Participants
- Registration Number
- NCT01520142
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 19
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment JNJ-26528398 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method The TNF-α concentrations in plasma (Part 2) Days 7-8
- Secondary Outcome Measures
Name Time Method Other markers of inflammation in blood (Part 2) Days 7-8 Profile of Mood States (POMS) (Part 2) 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) Days -1 to 10 and Day 24 Area under the curve (AUC) of JNJ-26528398 (Parts 1 and 2) Days 1-10 Blood concentrations sampled at frequent intervals
Maximum plasma concentration (Cmax) of JNJ-26528398 (Parts 1 and 2) Days 1-10