Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of Single and Multiple Ascending Doses of JNJ-41443532 in Healthy Male Participants

NCT ID: NCT01106469

Last Updated: 2014-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-07-31

Brief Summary

The purpose of this study is to investigate the safety, tolerability, food effect as well as the pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and how it is removed from the body over time) and pharmacodynamics (the effects of the drug) of single and multiple ascending doses of JNJ-41443532 in healthy male participants.

Detailed Description

This is a randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled, single and multiple ascending dose study conducted at a single study center. The study has 4 parts. Part 1 is a randomized, double-blind, alternating panel, single ascending oral dose study. Two alternating treatment panels (A and B) each with nine healthy male participants will be studied with successively increasing dose levels. Part 2 is a randomized, open-label (all people involved know the identity of the intervention), 2-period crossover study to evaluate what the effect of administering JNJ- 41443532 with food (i.e. standard high fat breakfast meal) relative to administration in the fasted state will have on pharmacokinetics/blood levels of JNJ-41443532. Part 3 is a randomized, double-blind, single oral dose study in obese, otherwise healthy male participants. Part 4 is a double-blind, randomized, placebo-controlled multiple ascending dose study in up to 5 sequential treatment groups of healthy male participants. Safety assessments include monitoring of adverse events, and evaluation of lab results, cardiac parameters, vital signs, and physical exams. In Parts 1, 2, and 3 participants receive study medication (JNJ-41443532 or placebo) orally on Day 1 after an overnight fast of at least 10 hours; planned doses are 25 to 1500 mg. In Part 4, participants receive study medication (JNJ-41443532 or placebo) orally each day for 10 consecutive days after an overnight fast of at least 10 hours; planned doses are 100 to 1000 mg.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

001

JNJ-41443532 25mg tablet once daily

Group Type: EXPERIMENTAL

JNJ-41443532

Intervention Type: DRUG

25mg tablet once daily

002

JNJ-41443532 100mg tablet once daily

Group Type: EXPERIMENTAL

JNJ-41443532

Intervention Type: DRUG

100mg tablet once daily

003

JNJ-41443532 250mg tablet once daily

Group Type: EXPERIMENTAL

JNJ-41443532

Intervention Type: DRUG

250mg tablet once daily

004

JNJ-41443532 500mg once daily (with 250mg tablets)

Group Type: EXPERIMENTAL

JNJ-41443532

Intervention Type: DRUG

500mg once daily (with 250mg tablets)

005

JNJ-41443532 1000mg once daily (with 250mg tablets)

Group Type: EXPERIMENTAL

JNJ-41443532

Intervention Type: DRUG

1000mg once daily (with 250mg tablets)

006

JNJ-41443532 1500mg once daily (with 250mg tablets)

Group Type: EXPERIMENTAL

JNJ-41443532

Intervention Type: DRUG

1500mg once daily (with 250mg tablets)

007

Placebo Matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo

Interventions

JNJ-41443532

25mg tablet once daily

Intervention Type: DRUG

JNJ-41443532

250mg tablet once daily

Intervention Type: DRUG

JNJ-41443532

1500mg once daily (with 250mg tablets)

Intervention Type: DRUG

JNJ-41443532

100mg tablet once daily

Intervention Type: DRUG

JNJ-41443532

1000mg once daily (with 250mg tablets)

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: DRUG

JNJ-41443532

500mg once daily (with 250mg tablets)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Males, age 18 to 45 years inclusive for Part 1 and age 18 to 55 years inclusive for Parts 2, 3, and 4
• Weight = 60 kilograms and Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive)
• BMI between 30 to 39.9 kg/m2 for obese participants
• Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram (ECG), and clinical laboratory tests performed at screening
• Men must agree to use a double barrier method of birth control (e.g. condom and use of spermicide with diaphragm, hormonal contraceptives or intrauterine devices by female partner) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
• Willing to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria

• History of, or currently active, significant illness or medical disorders, including (but not limited to) cardiovascular disease (including cardiac arrhythmias, myocardial infarction, stroke, peripheral vascular disease), endocrine or metabolic disease (e.g. hyper/hypo-thyroidism), hematological disease (e.g. von Willebrand's disease or other bleeding disorders), respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmologic disorders (including retinal disorders or cataracts), neoplastic disease, skin disorder, or any other illness that the Investigator considers should exclude the participant
• Participants at risk for QTc prolongation (specific heart rhythm irregularity)
• Within 12 months prior to screening, has had a clinically important, serious infection (e.g. hepatitis, pneumonia, or pyelonephritis), has been hospitalized for an infection or has been treated with intravenous (IV) antibiotics for an infection
• Smoker or tobacco user within the past 3 months
• History of alcohol or drug abuse
• History of clinically significant drug and/or food allergies, including allergies or intolerance (e.g. lactose intolerance)
• Donation of 1 or more units of blood or acute loss of an equivalent amount of blood within 60 days prior to study drug administration
• Received an experimental drug or used an experimental medical device within 60 days

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Merksem, , Belgium

Countries

Belgium

Other Identifiers

41443532EDI1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR017065

Identifier Type: -

Identifier Source: org_study_id