Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of Single and Multiple Ascending Doses of JNJ-41443532 in Healthy Male Participants
April 7, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of JNJ-41443532 in Healthy Male Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Merksem, Belgium
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 001
JNJ-41443532 25mg tablet once daily
|
25mg tablet once daily
250mg tablet once daily
1500mg once daily (with 250mg tablets)
100mg tablet once daily
1000mg once daily (with 250mg tablets)
500mg once daily (with 250mg tablets)
|
|
Experimental: 002
JNJ-41443532 100mg tablet once daily
|
25mg tablet once daily
250mg tablet once daily
1500mg once daily (with 250mg tablets)
100mg tablet once daily
1000mg once daily (with 250mg tablets)
500mg once daily (with 250mg tablets)
|
|
Experimental: 003
JNJ-41443532 250mg tablet once daily
|
25mg tablet once daily
250mg tablet once daily
1500mg once daily (with 250mg tablets)
100mg tablet once daily
1000mg once daily (with 250mg tablets)
500mg once daily (with 250mg tablets)
|
|
Experimental: 004
JNJ-41443532 500mg once daily (with 250mg tablets)
|
25mg tablet once daily
250mg tablet once daily
1500mg once daily (with 250mg tablets)
100mg tablet once daily
1000mg once daily (with 250mg tablets)
500mg once daily (with 250mg tablets)
|
|
Experimental: 005
JNJ-41443532 1000mg once daily (with 250mg tablets)
|
25mg tablet once daily
250mg tablet once daily
1500mg once daily (with 250mg tablets)
100mg tablet once daily
1000mg once daily (with 250mg tablets)
500mg once daily (with 250mg tablets)
|
|
Experimental: 006
JNJ-41443532 1500mg once daily (with 250mg tablets)
|
25mg tablet once daily
250mg tablet once daily
1500mg once daily (with 250mg tablets)
100mg tablet once daily
1000mg once daily (with 250mg tablets)
500mg once daily (with 250mg tablets)
|
|
Placebo Comparator: 007
Placebo Matching placebo
|
Matching placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Determine the pharmacokinetic properties of single and multiple doses JNJ-41443532 as determined by blood level concentrations.
Time Frame: Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks
|
Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Determine the safety and tolerability of JNJ-41443532 as determined by evaluation of adverse events, lab results, cardiac monitoring, vital signs, and physical exams.
Time Frame: Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks
|
Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks
|
|
To explore the relationship between JNJ-41443532 plasma concentrations and pharmacodynamic effects (concentration-effect relationships).
Time Frame: Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks
|
Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks
|
|
To explore the pharmacodynamic (PD) effects of JNJ-41443532 and to compare the differences between treatment groups
Time Frame: Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks
|
Part 1 - Approximately 13 weeks; Part 2 - Approximately 7 weeks; Part 3 - Approximately 6 weeks; Part 4 - Approximately 7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
April 15, 2010
First Submitted That Met QC Criteria
April 19, 2010
First Posted (Estimate)
April 20, 2010
Study Record Updates
Last Update Posted (Estimate)
April 8, 2014
Last Update Submitted That Met QC Criteria
April 7, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- CR017065
- 41443532EDI1001 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.