A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Participants

June 24, 2013 updated by: Janssen Research & Development, LLC

A Double-Blind, Randomized, Placebo-Controlled, Sequential Group, Single Ascending and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-39439335 in Healthy Japanese and Caucasian Adult Male Subjects

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of JNJ-39439335 in healthy Japanese and Caucasian adult male participants in Part 1, and in healthy Japanese adult male participants in Part 2.

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 double-blind (neither physician nor participant knows the treatment that the participant receives), randomized (the study drug is assigned by chance), placebo-controlled study (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial). The study consists of 2 Parts. In Part 1, three groups of healthy Japanese men and 3 groups of healthy Caucasian men will receive a single oral dose of JNJ-39439335 or placebo on Day 1. Each group will include 8 participants. The study duration of Part 1 for each participant is approximately 8 weeks: screening phase of up to 28 days prior to dose, treatment phase of 14 days, and a follow-up phase of 14 to16 days. In Part 2, three groups of healthy Japanese men will receive once-daily doses of either JNJ-39439335 or placebo for 21 days. Each group will include 12 participants. The study duration of Part 2 for each participant is approximately 11 weeks: screening phase of up to 28 days prior to dose, treatment phase of 21 days, and a follow-up phase of approximately 28 days. During the treatment phases, the participants will remain in the study unit. Blood samples and urine will be collected for drug concentration measurements and laboratory safety assessments.

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.
86

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

20 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Japanese or Caucasian participants
  • Nonsmoker
  • Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive, and body weight not less than 50 kg
  • Healthy on the basis of a physical examination, vital signs, hematology, coagulation, serum chemistry (including liver function tests) and urinalysis
  • Willing to adhere to the prohibitions and restrictions specified by the study protocol

Exclusion Criteria:

  • Oral temperatures > 37.5 Celsius degrees
  • Participants who have occupations or hobbies in which they are routinely exposed to situations in which they could sustain thermal burns
  • Abnormal electrocardiogram (ECG) results
  • Clinically significant abnormal values for hematology, clinical chemistry or urinalysis
  • History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • 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: Japanese Group 1: JNJ-39439335/placebo (Part 1)
Drug: JNJ-39439335 10 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
EXPERIMENTAL: Japanese Group 2: JNJ-39439335/placebo (Part 1)
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
Drug: JNJ-39439335 25 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.
EXPERIMENTAL: Japanese Group 3: JNJ-39439335/placebo (Part 1)
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
Drug: JNJ-39439335 50 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.
EXPERIMENTAL: Caucasian Group 1: JNJ-39439335/placebo (Part 1)
Drug: JNJ-39439335 10 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
EXPERIMENTAL: Caucasian Group 2: JNJ-39439335/placebo (Part 1)
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
Drug: JNJ-39439335 25 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.
EXPERIMENTAL: Caucasian Group 3: JNJ-39439335/placebo (Part 1)
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
Drug: JNJ-39439335 50 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.
EXPERIMENTAL: Japanese Group 1: JNJ-39439335/placebo (Part 2)
Drug: JNJ-39439335 10 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
EXPERIMENTAL: Japanese Group 2: JNJ-39439335/placebo (Part 2)
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
Drug: JNJ-39439335 25 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.
EXPERIMENTAL: Japanese Group 3: JNJ-39439335/placebo (Part 2)
Drug: Placebo
Multiple (once daily for 21 days) oral doses of matching placebo.
Drug: JNJ-39439335 50 mg
Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.

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
Plasma concentrations of JNJ-39439335 (Part 1)
Time Frame: up to 14 days
up to 14 days
Urine concentrations of JNJ-39439335 (Part 1)
Time Frame: up to 5 days
up to 5 days
Plasma concentrations of JNJ-39439335 (Part 2)
Time Frame: up to 21 days
up to 21 days
Urine concentrations of JNJ-39439335 (Part 2)
Time Frame: up to 21 days
up to 21 days

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
Incidence of Adverse Events (Part 1)
Time Frame: Approximately 8 weeks
Approximately 8 weeks
Incidence of Adverse Events (Part 2)
Time Frame: Approximately 11 weeks
Approximately 11 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.
Janssen Research & Development, LLC

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.
July 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

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.
March 1, 2013

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).
June 27, 2012

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.
June 27, 2012

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.
June 29, 2012

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.
June 25, 2013

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.
June 24, 2013

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.
June 1, 2013

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.
  • CR100890
  • 39439335PAI1005 (OTHER: Janssen Research & Development, LLC)

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.

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