Pharmacokinetic Study of JNJ-42756493 in Healthy Participants

January 7, 2015 updated by: Janssen Research & Development, LLC

A Single-Dose, Open-Label, Randomized, Two-Way Crossover Pharmacokinetic Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Following Intake of a Tablet Versus a Solution and to Assess the Absolute Bioavailability of Orally Administered JNJ-42756493 Following Concomitant Administration of an Intravenous Microdose of the Stable Isotope JNJ-61818549 in Healthy Subjects

The purpose of this study is to evaluate the absolute bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-42756493 following a single 10 milligram (mg) dose as an oral solution administered in combination with a single intravenous administration of a microdose (100 microgram [mcg]) of JNJ-61818549 and to evaluate the relative bioavailability of 10 mg JNJ-42756493 following an oral solution (reference) and a tablet (test) formulation in a crossover (method used to switch subjects from one study group to another in a clinical trial) design in healthy 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), open-label (all people know the identity of the intervention), 2-way crossover, single-dose, and single-center, Phase 1 study of oral JNJ-42756493 in healthy participants. The duration of the study is approximately 36-63 days: 2-20 days Screening, two 7 days open-label treatment periods, 12-14 days washout and 12-14-day follow-up (Day 13-15 of period 2). All participants will be randomly assigned to 1 of 2 treatment sequences. In Treatment Sequence AB: JNJ-42756493 10 mg tablet formulation will be administered on Day 1 of Period 1 and 100 mcg JNJ-61818549 will be administered intravenously 2 hours after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 2. In Treatment Sequence BA: 100 mcg JNJ-61818549 will be administered intravenously after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 1 and 10 mg JNJ-42756493 tablet formulation will be administered on Day 1 of Period 2. A minimum 12 days washout is required between treatment periods. Participants will primarily be analyzed for pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time). Participants' 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.
8

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

All

Description

Inclusion Criteria:

  • Received a thorough explanation of the optional pharmacogenomic research component of the study and was offered an opportunity to participate by signing the separate pharmacogenomic informed consent document
  • If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), or surgically sterile
  • If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening
  • Body mass index (BMI) (weight kilogram [kg]/ height square meter[m^2] between 18 and 30 kg/m^2 (inclusive), and body weight not less than 50 kg
  • Non-smoker for at least 6 months before entering the study

Exclusion Criteria:

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, metabolic bone disease (other than osteoporosis), infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
  • Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening and predose on Day -2 (urinalysis only) and on Day -1 of both treatment Period as deemed appropriate by the investigator. Retesting of abnormal lab values that may lead to exclusion will be allowed once
  • Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) at screening and Day -1 of both treatment Periods as deemed appropriate by the investigator
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
  • History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years

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: Crossover Assignment
  • Masking: None (Open Label)

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: Treatment Sequence AB
Participants will receive 10 milligram (mg) JNJ-42756493 tablet orally on Day 1 of Period 1 and 100 microgram (mcg) of JNJ-61818549 as intravenous injection 2 hours after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 2.
Drug: JNJ-42756493 10 mg tablet
Participants will be administered with 10 milligram (mg) JNJ-42756493 tablet orally either on Day 1 of Period 1 or on Day 1 of Period 2.
Drug: JNJ-42756493 10 mg Oral Solution
Participants will be administered with 10 mg JNJ-42756493 oral solution either on Day 1 of Period 1 or on Day 1 of Period 2.
Drug: JNJ-61818549
Participants will receive 100 mcg of JNJ-61818549 as intravenous injection on Day 1 of Period 2 or Day 1 of Period 1.
Experimental: Treatment Sequence BA
Participants will receive 100 mcg of JNJ-61818549 as intravenous injection after the intake of 10 mg JNJ-42756493 oral solution on Day 1 of Period 1 and JNJ-42756493 10 mg tablet orally on Day 1 of Period 2.
Drug: JNJ-42756493 10 mg tablet
Participants will be administered with 10 milligram (mg) JNJ-42756493 tablet orally either on Day 1 of Period 1 or on Day 1 of Period 2.
Drug: JNJ-42756493 10 mg Oral Solution
Participants will be administered with 10 mg JNJ-42756493 oral solution either on Day 1 of Period 1 or on Day 1 of Period 2.
Drug: JNJ-61818549
Participants will receive 100 mcg of JNJ-61818549 as intravenous injection on Day 1 of Period 2 or Day 1 of Period 1.

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
Measure Description
Time Frame
Relative Bioavailability: Maximum Plasma Concentration (Cmax)
Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
The Cmax is the maximum observed plasma concentration of JNJ-42756493.
Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
Absolute Bioavailability
Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
Absolute bioavailability will be measured by Area under concentration time-curve (AUC [0-24]), AUC (0-last) and AUC (0-infinity).
Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
Relative Bioavailability: Area under concententration time-curve (AUC)
Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
Relative bioavailability will be measured by AUC (0-24), AUC (0-last) and AUC (0-infinity).
Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose

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
Measure Description
Time Frame
Time to Reach Maximum Concentration (tmax)
Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
The tmax is time to reach the maximum observed plasma concentration.
Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
Elimination Half-Life (t1/2)
Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.
Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose

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.
October 1, 2014

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.
December 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.
December 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).
August 14, 2014

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.
August 14, 2014

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.
August 15, 2014

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.
January 8, 2015

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.
January 7, 2015

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.
January 1, 2015

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.
  • CR104998
  • 42756493EDI1002 (Other Identifier: Janssen Research & Development, LLC)
  • 2014-002634-31 (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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