A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Participants

September 11, 2014 updated by: Janssen Cilag N.V./S.A.

A Double Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Subjects

The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of single oral doses and multiple oral doses of JNJ-38877618 administered for 7 consecutive days in healthy adult 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 (individuals assigned to study treatment by chance), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in healthy adult male participants aged 18 to 45 years (a single optional cohort in older healthy male participants aged 50 to 65 years may be included). If all optional cohorts are included, up to 144 participants may be enrolled. This study will consist of up to four parts. Part 1 contains up to 3 subparts: Part 1a is a double-blind, placebo-controlled, single ascending dose design (SAD) with a liquid formulation (Formulation A); Part 1b is an open-label (identity of assigned study drug will be known), single dose evaluation of a capsule formulation (Formulation B); and Part 1c is an optional open-label, single dose evaluation of a capsule formulation (Formulation C). Part 2 is the completion of the double-blind, placebo-controlled SAD after a formulation has been selected based on Parts 1a, 1b, and 1c (if applicable). Part 3 is a double-blind, placebo-controlled, multiple ascending dose design (MAD). Doses for Part 3 will be determined based on the safety, tolerability, and pharmacokinetics (study of what the body does to a drug) in Parts 1 and 2. Part 4 is an optional double-blind, placebo-controlled, single dose evaluation in older healthy male participants. Serial pharmacokinetic and pharmacodynamics (study of what a drug does to the body) samples will be collected and safety will be monitored throughout the study.

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.
84

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Deemed healthy on the basis of physical examination, medical history, laboratory tests, vital signs, and 12-lead electrocardiogram within protocol-defined parameters performed at screening and Day -1
  • Must have good exercise tolerance
  • Agrees to protocol-defined use of effective contraception
  • Body Mass Index between 20 and 30 kg/m2 and body weight not less than 65 kg
  • Non-nicotine user for 6 months prior to screening

Exclusion Criteria:

  • Current history of clinically significant medical illness
  • History of drug or alcohol abuse within 5 years
  • Routine consumption of >450 mg of caffeine per day
  • Recent vaccination or acute illness
  • Blood donation or major blood loss within 3 months prior to study drug administration
  • Use of any prescription or over-the-counter medication (not including paracetamol), or herbal medication within 2 weeks of dosing of the study drug or a proton pump inhibitor within 6 weeks prior to dosing of study drug
  • Currently enrolled in an investigational study, or received an investigational drug or vaccine, or used an invasive investigational medical device within 3 months before the planned first dose of study drug
  • Plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
  • Major surgery within 3 months before or after study participation or minor surgery within 6 weeks before screening, or 30 days after the last study drug administration
  • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

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.
PLACEBO_COMPARATOR: Placebo
Drug: Placebo: Parts 1a, 2, 3, and 4 (optional)
Administered orally matched to study drug
EXPERIMENTAL: JNJ-38877618
Drug: JNJ-38877618: Part 1a
Single ascending dose administered orally in liquid formulation (Formulation A). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
Drug: JNJ-38877618: Part 1b
Single dose administered orally in capsule formulation (Formulation B). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
Drug: JNJ-38877618: Part 1c (optional)
Single dose administered orally in an alternative capsule formulation (Formulation C). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
Drug: JNJ-38877618: Part 2
Single ascending dose administered orally in the formulation selected based on Parts 1a, 1b, and 1c (if applicable). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
Drug: JNJ-38877618: Part 3
Multiple ascending dose and formulation determined in Part 2 (not to exceed 600 mg) administered orally.
Drug: JNJ-38877618: Part 4 (optional)
Single dose and formulation as determined in Part 3 administered orally in older healthy male participant cohort.

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
Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
Time Frame: Up to 30 days after the last dose of study medication
Up to 30 days after the last dose of study medication
Time to reach the maximum observed plasma concentration of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Area under the plasma concentration-time curve from time 0 to 24-hours post dose of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration
Time Frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Area under the plasma concentration-time curve from time 0 to infinite time of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Elimination half-life of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
First-order rate constant associated with the terminal portion of the curve of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Total clearance of drug after oral administration of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Apparent volume of distribution after oral administration of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Up to 24 hours after last dose of study medication (up to Part 4 Day 2)
Maximum observed plasma concentration during a dosing interval at steady state of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Minimum observed plasma concentration during a dosing interval at steady state of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Average plasma concentration over the dosing interval at steady state of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Trough observed plasma concentration at the end of dosing interval of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Time to reach the maximum observed plasma concentration of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Area under the plasma concentration-time curve during a dosing interval of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Area under the plasma concentration-time curve during a dosing interval at steady-state of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Total clearance of drug after oral administration of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Accumulation index of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Apparent volume of distribution at steady-state after oral administration of JNJ-38877618
Time Frame: Up to 24 hours after last dose of study medication (up to Part 3 Day 8)
Up to 24 hours after last dose of study medication (up to Part 3 Day 8)

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
Maximum tolerated dose of JNJ-38877618
Time Frame: Up to 30 days after last dose of study medication (up to Part 2)
Up to 30 days after last dose of study medication (up to Part 2)

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 Cilag N.V./S.A.

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.
November 1, 2013

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.
May 1, 2014

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.
May 1, 2014

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).
October 15, 2013

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.
October 15, 2013

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.
October 17, 2013

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.
September 12, 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.
September 11, 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.
September 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.
  • CR102784
  • 38877618EDI1001 (OTHER: Janssen Cilag N.V./S.A., Belgium)
  • 2013-002551-16 (EUDRACT_NUMBER)

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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