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

Phase 1CompletedNCT01520142

Janssen Research & Development, LLC19 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Participants

Interventions

JNJ-26528398DRUG

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.

PlaceboDRUG

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Antwerp, Belgium

Outcomes

Primary Outcomes

The TNF-α concentrations in plasma (Part 2)

Time frame: Days 7-8

Secondary Outcomes

Other markers of inflammation in blood (Part 2)

Time frame: Days 7-8

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).

Time frame: Days 1 and 7

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)

Blood concentrations sampled at frequent intervals

Time frame: Days 1-10

Maximum plasma concentration (Cmax) of JNJ-26528398 (Parts 1 and 2)

Time frame: Days 1-10

Data from ClinicalTrials.gov

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