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

NCT ID: NCT01520142

Last Updated: 2013-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-04-30

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

Group Type: EXPERIMENTAL

JNJ-26528398

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC and Development, L.L.C. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

26528398EDI1001

Identifier Type: OTHER

Identifier Source: secondary_id

2011-004459-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100754

Identifier Type: -

Identifier Source: org_study_id