Clinical trial NCT01520142: Safety, Tolerability and Pharmacodynamic Activity of JNJ-26528398 in Healthy Male Participants
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy participants
Pharmacodynamic
Pharmacokinetics
Intravenous Endotoxin-Induced Model
Acute Inflammation
JNJ-26528398
Anti-inflammatory
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-01-27
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The TNF-α concentrations in plasma (Part 2)
timeFrame: Days 7-8
Secondary outcomes:
measure: Other markers of inflammation in blood (Part 2)
timeFrame: Days 7-8
measure: Profile of Mood States (POMS) (Part 2)
timeFrame: Days 1 and 7
measure: Incidence of adverse events amongst participants (Parts 1 and 2)
timeFrame: Days -1 to 10 and Day 24
measure: Area under the curve (AUC) of JNJ-26528398 (Parts 1 and 2)
timeFrame: Days 1-10
measure: Maximum plasma concentration (Cmax) of JNJ-26528398 (Parts 1 and 2)
timeFrame: Days 1-10
Other outcomes:
Locations:
city: Antwerp
country: Belgium
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC and Development, L.L.C. Clinical Trial
role: STUDY_DIRECTOR
References: