- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02555124
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-42847922 in Healthy Japanese Male Participants
March 9, 2017 updated by: Janssen Pharmaceutical K.K.
A Double-Blind, Placebo-Controlled, Randomized, Single-Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-42847922 in Healthy Japanese Male Subjects
The purpose of this study is to evaluate the safety of JNJ-42847922 following single oral administration.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a single center, double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), randomized (study medication assigned to participants by chance), single-ascending dose study.
The study consists of a screening phase, an in-clinic treatment phase, and a follow-up phase.
The study duration for each subject will be approximately 5 weeks from screening (Day -28 to Day -3), in-clinic period (Day -2 to Day 4) to follow up visit (Day 8).
Participants will receive a single oral dose of JNJ-42847922 or placebo in 3 cohorts.
Participants' safety will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- 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
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Osaka, Japan
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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
Ages Eligible for Study
20 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Participant must be willing and able to adhere to the prohibitions and restrictions specified inprotocol, Prohibitions and Restrictions
- A man who is sexually active with a woman of childbearing potential and has not had avasectomy must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception), and all men must also agree not to donate sperm during the study and for 3 months afterreceiving the last dose of study drug
- Participant must have a body mass index (BMI) between 18.0 and 29.9 kilogram per square meter (kg/m^2), and body weight not less than 50 kg
- Participant must have a 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, Including: Synus rhythm; Heart rate between 45 and 99 beats per minute (bpm); QT corrected according to Fridericia's formula (QTcF) interval less than or equal to (<=)450 milliseconds (ms); QRS interval of <=120 ms; PR interval <=220 ms; Morphology consistent with healthy cardiac conduction and function
- Nonsmoker (not smoked for 3 months prior to screening)
Exclusion Criteria:
- Participant has a history of or current clinically significant medical illness including (but notlimited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulationdisorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities,significant pulmonary disease, including bronchospastic respiratory disease, diabetesmellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease,infection, or any other illness that the investigator considers should exclude the participant orthat could interfere with the interpretation of the study results
- Participant has a clinically significant abnormal value for hematology, coagulation,biochemistry, or urinalysis at screening as deemed appropriate by the investigator
- Participant has a clinically significant abnormal physical examination, neurologic examination,or vital signs as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbalsupplements), except for acetaminophen within 14 days before study drug administration onDay 1
- Participant has known allergies, hypersensitivity, or intolerance to JNJ-42847922 or its excipients
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 |
Intervention / Treatment |
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Experimental: Cohort A
Participants will receive single oral dose of 5 milligram (mg) of JNJ-42847922 or Placebo on Day 1, fasted condition.
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Participants will receive single oral dose of 5 milligram (mg) of JNJ-42847922 on Day 1, fasted condition.
Participants will receive placebo on Day 1, fasted condition in Cohort A, Cohort B and Cohort C.
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Experimental: Cohort B
Participants will receive single oral dose of 20 mg of JNJ-42847922 or Placebo on Day 1, fasted condition.
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Participants will receive placebo on Day 1, fasted condition in Cohort A, Cohort B and Cohort C.
Participants will receive single oral dose of 20 mg of JNJ-42847922 on Day 1, fasted condition.
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Experimental: Cohort C
Participants will receive single oral dose of 40 mg of JNJ-42847922 or Placebo on Day 1, fasted condition.
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Participants will receive placebo on Day 1, fasted condition in Cohort A, Cohort B and Cohort C.
Participants will receive single oral dose of 40 mg of JNJ-42847922 on Day 1, fasted condition.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events (AEs)
Time Frame: up to Day 8
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An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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up to Day 8
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Number of Participants With Serious Adverse Events (SAEs)
Time Frame: up to Day 8
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An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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up to Day 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Plasma Concentration (Cmax)
Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Cmax is the maximum observed plasma concentration.
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Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Time to Reach the Maximum Observed Plasma Concentration (Tmax)
Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Tmax is the time to reach the maximum observed plasma concentration.
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Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Time to Last Time of the Last Measurable (nonbelow quantification limit [nonBQL]) Plasma Concentration (Tlast)
Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Tlast is the time to last time of the last measurable (nonbelow quantification limit [nonBQL]) plasma concentration.
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Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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AUC From Time 0 to the Time of the Last Measurable (nonBQL) Plasma Concentration (AUClast)
Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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AUClast is the area under the plasma concentraion curve from time 0 to the time of the last measurable (nonBQL) plasma concentration.
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Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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The AUC(0-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; C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
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Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Percentage of Area Under the Plasma Concentrationtime Curve Obtained by Extrapolation (%AUC [infinity,ex])
Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Percentage of area under the plasma concentration-time curve obtained by extrapolation (%AUC[inf,ex]) is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100 (AUC[0-infinity] - AUC[0-last])*100/AUC[0-infinity].
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Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Apparent Elimination Half-life (t1/2)
Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Elimination half-life (t [1/2]) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
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Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Apparent Terminal Elimination Rate Constant (Lambda[z])
Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Lambda(z) is 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.
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Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Total Apparent Clearance (CL/F)
Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Total apparent clearence is calculated as dose divided by AUC(infinity).
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Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Apparent Volume of Distribution (Vd/F)
Time Frame: Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Apparent volume of distribution is calculated as Dose divided by Lambda[z] multiplied by AUC(infinity).
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Day 1 (pre-dose), 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12,16 hour (hr) post-dose on Day 1; 24, 36 hr post-dose on Day 2; 48, 60 hr post-dose on Day 3; 72 hr post-dose on Day 4
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Change From Baseline in Stanford Sleepiness Scale Score at Day 1
Time Frame: Baseline and Day 1
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The Stanford Sleepiness Scale (SSS) is a subjective rating of sleepiness, with score ranging from 1 to 7, where higher values reflect more severe sleepiness
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Baseline and Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
September 12, 2015
Primary Completion (Actual)
October 31, 2015
Study Completion (Actual)
October 31, 2015
Study Registration Dates
First Submitted
September 18, 2015
First Submitted That Met QC Criteria
September 18, 2015
First Posted (Estimate)
September 21, 2015
Study Record Updates
Last Update Posted (Actual)
March 10, 2017
Last Update Submitted That Met QC Criteria
March 9, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CR107878
- 42847922ISM1002 (Other Identifier: Janssen Pharmaceutical K.K., Japan)
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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