A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42847922 in Healthy Participants

January 21, 2017 updated by: Janssen-Cilag International NV

A Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-42847922 in Healthy Male and Female Subjects

The purpose of this study is to investigate the safety, tolerability, pharmacokinetic (the study of the way a drug enters and leaves the blood and tissues over time), dose-proportionality, accumulation, urinary excretion, pharmacodynamics (the study of how drugs act on the body) and sedative effects of JNJ-42847922 in healthy male and female 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 Phase 1, double blind (a medical research study in which neither the researchers nor the participants know what treatment the participants is receiving), randomized (study drug assigned by chance), placebo controlled, multiple ascending dose study. The study will consist of 3 parts: a Screening period (Days -21 to -2), a Double-blind treatment period (Day -1 to Day 11), and a Follow-up period (within 7 to 14 days after last dose administration). In double blind treatment period, participants will be randomly assigned to 5, 10, 20, and 40 milligram (mg) or placebo. Number of participants with any clinically relevant changes (adverse events [AEs], laboratory results,electrocardiogram [ECG], Vital signs, Physical and neurological, sedation & concentration) and columbia suicide severity rating (CSSR) scale will be evaluated as primary outcome measure. 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.
40

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:

  • Women should not be of child bearing potential due to either tubal ligation or hysterectomy or who are postmenopausal (no spontaneous menses for at least 2 years
  • Body Mass Index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) inclusive (BMI=weight/height^2)
  • Participants must be healthy / medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value(s) that may lead to exclusion will be allowed once during the screening phase
  • Non-smokers (not smoked for 6 months prior to screening)
  • Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria:

  • Clinically significant abnormal values for hematology, serum chemistry or urinalysis at screening or admission
  • Clinically significant abnormal physical or neurological examination, vital signs or 12-lead electrocardiogram (ECG) at screening or admission
  • History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the participant
  • Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies
  • Subjects with a relevant history of a suicide attempt or suicidal behavior. Any recent suicidal ideation within the last 6 months (a level of 4 or 5), or who are at significant risk to commit suicide, as judged by the investigator using the columbia suicide severity rating score (C-SSRS)

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 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: JNJ-42847922, 5 milligram (mg) and Placebo
Participants will be receive either 5 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.
Drug: JNJ-42847922 5 mg
Participants will receive 5 mg of JNJ-42847922, from Day 1 up to Day 10.
Drug: Placebo
Participants will receive matching placebo from Day 1 up to Day 10.
Experimental: JNJ-42847922, 10 mg and Placebo
Participants will be receive either 10 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.
Drug: Placebo
Participants will receive matching placebo from Day 1 up to Day 10.
Drug: JNJ-42847922 10 mg
Participants will receive 10 mg of JNJ-42847922, from Day 1 up to Day 10.
Experimental: JNJ-42847922, 20 mg and Placebo
Participants will be receive either 20 mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.
Drug: Placebo
Participants will receive matching placebo from Day 1 up to Day 10.
Drug: JNJ-42847922 20 mg
Participants will receive 20 mg of JNJ-42847922, from Day 1 up to Day 10.
Experimental: JNJ-42847922, 40 mg and Placebo
Participants will be receive either 40mg of JNJ-42847922 from Day 1 up to Day 10 or matching placebo from Day 1 up to Day 10.
Drug: Placebo
Participants will receive matching placebo from Day 1 up to Day 10.
Drug: JNJ-42847922 40 mg
Participants will receive 40 mg of JNJ-42847922, from Day 1 up to Day 10 .

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
Supine and Standing Systolic and Diastolic Blood Pressure (BP)
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Supine and Standing Heart Rate
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Tympanic Temperature
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
12 Lead Electrocardiogram (ECG): RR, QRS, PR, QT, QTcB, QTcF Interval
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Number of Participants with Adverse Events
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Number of Participants With Change From Baseline in Laboratory Tests Results
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Laboratory values included Hematology, clinical chemistry and urinalysis.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Physical and Neurological Examination
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Physical and neurological examination will be performed.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal

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
Maximum Plasma Concentration (C[max])
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
The C(max) is the maximum plasma concentration which will be observed at the defined time points.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Time to Reach the Maximum Plasma Concentration (T[max])
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
The T[max] is time to reach the observed maximum plasma concentration.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Time to Reach Last Quantifiable Plasma Concentration (T[last])
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
The T[last] is time to reach the observed maximum plasma concentration.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Area Under the Plasma Concentration-Time Curve From Time Zero to hour 24 Time (AUC [0-24])
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
AUC (0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours post-dose.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last])
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
AUC (last) is the area under the plasma concentration-time curve from time zero time of the last quantifiable concentration C(last), and C(last) is the last observed quantifiable concentration.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Average Plasma Concentration at Steady-State (C[avg])
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
C(avg) is the average plasma concentration at steady state, calculated as AUC 0-24 divided by 24
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Trough Plasma Concentration (C[trough])
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Trough plasma concentration is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Total Clearance (CL/F)
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
CL/F is the total clearance of drug after extravascular administration, uncorrected for absolute bioavailability. It is calculated as Dose divided by AUC.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Volume of Distribution (Vd/F)
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Vd/F is the volume of distribution after extravascular administration, uncorrected for absolute bioavailability.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Elimination Half-life Period (t1/2)
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Elimination half-life associated with the terminal slope (lambda[z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda (z).
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Terminal slope (Lambda [z])
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Terminal slope is defined by first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Mean Residence Time (MRT)
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
MRT is the mean residence time calculated as area under the first moment curve at infinity (AUMC[0-∞]) divided by AUC[0-∞].
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Amount of Drug Excreted in Urine (Ae)
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Ae is the amount of urine excreted in urine. It is calculated by multiplying the urinary volume with the urinary concentration.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Amount of Drug Excreted into Urine During the 24-hour Dosing Interval (Ae[0-24])
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Ae(0-24h) is the amount of drug excreted into urine during the 24-hour dosing interval.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Percentage of Drug Excreted in Urine (Ae%dose)
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Ae%dose is the percentage of drug excreted into the urine calculated as (Ae divided by dose)∗100.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Renal Clearance (CL[R])
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
CL(R) is the renal clearance of the drug, calculated as Ae/AUC[0-infinity] on Day 1 or Ae(0-24)/AUC(0-24) on Day 5 and Day 10.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of Sedation
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Sedation will be assessed using a reaction time (RT) test battery, the Critical Flicker Fusion (CFF) test and body sway.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Bond and Lader Visual Analogue Scale (B and L VAS)
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
The B and L VAS includes 16 questions with VAS scales to rate subjective feelings.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal
Addiction Research Center Inventory Questionnaire (ARCI-49)
Time Frame: Baseline up to End of study (7-14 days after last dose) or Early withdrawal
The ARCI-49 item questionnaire is developed specifically to measure subjective effects of drugs with diverse pharmacological actions.
Baseline up to End of study (7-14 days after last dose) or Early withdrawal

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 International NV

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.
May 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.
November 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.
November 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.
September 2, 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.
September 3, 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 24, 2017

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 21, 2017

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, 2017

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.
  • CR104154
  • 42847922EDI1003 (Other Identifier: Janssen-Cilag International NV)
  • 2014-000600-95 (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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