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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 001
JNJ-41443532 25mg tablet once daily
Drug: JNJ-41443532
25mg tablet once daily
Drug: JNJ-41443532
250mg tablet once daily
Drug: JNJ-41443532
1500mg once daily (with 250mg tablets)
Drug: JNJ-41443532
100mg tablet once daily
Drug: JNJ-41443532
1000mg once daily (with 250mg tablets)
Drug: JNJ-41443532
500mg once daily (with 250mg tablets)
Experimental: 002
JNJ-41443532 100mg tablet once daily
Drug: JNJ-41443532
25mg tablet once daily
Drug: JNJ-41443532
250mg tablet once daily
Drug: JNJ-41443532
1500mg once daily (with 250mg tablets)
Drug: JNJ-41443532
100mg tablet once daily
Drug: JNJ-41443532
1000mg once daily (with 250mg tablets)
Drug: JNJ-41443532
500mg once daily (with 250mg tablets)
Experimental: 003
JNJ-41443532 250mg tablet once daily
Drug: JNJ-41443532
25mg tablet once daily
Drug: JNJ-41443532
250mg tablet once daily
Drug: JNJ-41443532
1500mg once daily (with 250mg tablets)
Drug: JNJ-41443532
100mg tablet once daily
Drug: JNJ-41443532
1000mg once daily (with 250mg tablets)
Drug: JNJ-41443532
500mg once daily (with 250mg tablets)
Experimental: 004
JNJ-41443532 500mg once daily (with 250mg tablets)
Drug: JNJ-41443532
25mg tablet once daily
Drug: JNJ-41443532
250mg tablet once daily
Drug: JNJ-41443532
1500mg once daily (with 250mg tablets)
Drug: JNJ-41443532
100mg tablet once daily
Drug: JNJ-41443532
1000mg once daily (with 250mg tablets)
Drug: JNJ-41443532
500mg once daily (with 250mg tablets)
Experimental: 005
JNJ-41443532 1000mg once daily (with 250mg tablets)
Drug: JNJ-41443532
25mg tablet once daily
Drug: JNJ-41443532
250mg tablet once daily
Drug: JNJ-41443532
1500mg once daily (with 250mg tablets)
Drug: JNJ-41443532
100mg tablet once daily
Drug: JNJ-41443532
1000mg once daily (with 250mg tablets)
Drug: JNJ-41443532
500mg once daily (with 250mg tablets)
Experimental: 006
JNJ-41443532 1500mg once daily (with 250mg tablets)
Drug: JNJ-41443532
25mg tablet once daily
Drug: JNJ-41443532
250mg tablet once daily
Drug: JNJ-41443532
1500mg once daily (with 250mg tablets)
Drug: JNJ-41443532
100mg tablet once daily
Drug: JNJ-41443532
1000mg once daily (with 250mg tablets)
Drug: JNJ-41443532
500mg once daily (with 250mg tablets)
Placebo Comparator: 007
Placebo Matching placebo
Drug: Placebo
Matching placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings