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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: JNJ-26528398

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01520142

26528398EDI1001 (Other Identifier)

CR100754

2011-004459-38 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

Male

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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