HealthyPhase 1NCT02692677
A Study to Assess the Absorption, Metabolism, and Routes of Excretion Following Oral Administration of (14C) Radiolabeled JNJ--42756493 to Healthy Male Participants
A Phase 1 study testing JNJ-42756493 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the absorption, metabolism, and excretion of JNJ-42756493 in healthy male adult participants after administration of a single oral dose of 12 milligram (mg) of unlabeled JNJ-42756493 admixed with 14C JNJ-42756493. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-42756493
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to adhere to the prohibitions and restrictions specified in the protocol
- A man who is sexually active must agree to use a condom; and a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use a condom in combination with an adequate contraception method as deemed appropriate by the investigator (example, double-barrier method, partner using effective contraception [defined as hormonal contraception (pill, patch, injection), intrauterine device, surgical sterilization] and to not donate sperm for 5 months after receiving the study drug
- Body mass index (BMI; weight [kg]/height2 [m]2) between 18 and 30 kilogram per square meter (kg/m2) (inclusive), and body weight not less than 50 kg
Who cannot join
- 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, hepatic or renal insufficiency [creatinine clearance below 90 milliliter per minute (mL/min)], thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- History or current evidence of ophthalmic disorder, such as central serous retinopathy or retinal vein occlusion, active wet age related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
- Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) and clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at screening or at admission to the study center as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before dosing is scheduled until End-of-Study procedures
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and Day -2 of the treatment period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Phase 1 Study to Determine the Absorption, Metabolism, and Routes of Excretion Following Oral Administration of (14C) Radiolabeled JNJ-42756493 to Healthy Male Subjects
The purpose of this study is to assess the absorption, metabolism, and excretion of JNJ-42756493 in healthy male adult participants after administration of a single oral dose of 12 milligram (mg) of unlabeled JNJ-42756493 admixed with 14C JNJ-42756493.
Read the detailed description
This is a single--center, open--label (The researchers and participants know the treatment the participant is receiving) study. The study consists of 3 parts: Screening (35 days ), Open-label Treatment Phase (Day 1 up to Day 14 or 28); and Follow-up (up to 30 days). Total duration of the study is approximately 79 to 93 days. Plasma and urine will be collected for determination of JNJ-42756493 concentrations. Participants will be primarily evaluated for absorption, the metabolic pathways and the excretion of JNJ-42756493. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- JNJ-42756493
- Keywords
- Healthy, JNJ-42756493
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42756493Drug
Participants will receive a single oral solution at a dose of 12 milligram (mg) of unlabeled JNJ--42756493 admixed with 14C- labeled JNJ--42756493.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-42756493 | Experimental | Each participant will receive a single oral dose of 12 milligram (mg) of unlabeled JNJ-42756493 admixed with 14C JNJ-42756493 at Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14 Receives: Drug: JNJ-42756493 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Time to Reach Maximum Observed Plasma Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
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.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Apparent Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Apparent Volume of Distribution (Vd/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after subcutaneous dose (Vd/F) is influenced by the fraction absorbed.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Elimination Rate Constant
Lambda(z) is first-order elimination 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.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Unbound Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Unbound Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
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.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Amount of Drug Excreted in Urine (Ae)
The Ae is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Renal Clearance (CLR)
Renal clearance calculated as Ae/AUC (last).
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Area Under First Moment Plasma Concentration-Time Curve (AUMC)
AUMC is defined as the area under first moment plasma concentration-time curve from time of dosing up to definite time t, to infinity, or to the time of last measurable concentration determined by the following equation: AUMC(0 to infinity)=Cntn/k elimination(el) + Cn/k(el^2) summation[(tn - tn^-1) (Cn^-1) (tn^-1)] + Cntn/2 where Cn=last quantifiable concentration, tn=time at which Cn is measured, k=rate constant.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Elimination Half-Life Associated With the Terminal Slope
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve, calculated as 0.693/Lamda(z).
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Percentage of Drug Excreted in Urine (Ae%dose)
The Ae%dose is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Amount of Drug Excreted in Urine (Ae) from t1 to t2
Amount of drug excreted into urine over a given time interval from t1 to t2, where t1 and t2 are the start and end times of the interval.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Percentage of Extrapolated Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (Percentage AUCinfinity, extrapolated [%AUCinf,ex])
Percentage of the AUCinfinity obtained by extrapolation calculated by ratio between AUCinfinity minus AUClast versus AUCinfinity.
Measured: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Secondary outcomes (1)
Number of Participants With Adverse Events
An adverse event AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Baseline up to follow up (79 to 93 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692677
- Sponsor's protocol ID
- CR108125
- Other IDs
- 42756493EDI1005
- Status last verified
- Oct 2017
- First submitted
- 23 Feb 2016
- Last updated
- 23 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1 Study to Determine the Absorption, Metabolism, and Routes of Excretion Following Oral Administration of (14C) Radiolabeled JNJ-42756493 to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02692677
- Acronym / sponsor ID
- CR108125
- Conditions
- Healthy
- Keywords
- Healthy, JNJ-42756493
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the absorption, metabolism, and excretion of JNJ-42756493 in healthy male adult participants after administration of a single oral dose of 12 milligram (mg) of unlabeled JNJ-42756493 admixed with 14C JNJ-42756493.
Detailed description
This is a single--center, open--label (The researchers and participants know the treatment the participant is receiving) study. The study consists of 3 parts: Screening (35 days ), Open-label Treatment Phase (Day 1 up to Day 14 or 28); and Follow-up (up to 30 days). Total duration of the study is approximately 79 to 93 days. Plasma and urine will be collected for determination of JNJ-42756493 concentrations. Participants will be primarily evaluated for absorption, the metabolic pathways and the excretion of JNJ-42756493. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JNJ-42756493 | Experimental | Drug: JNJ-42756493Each participant will receive a single oral dose of 12 milligram (mg) of unlabeled JNJ-42756493 admixed with 14C JNJ-42756493 at Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14 |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Willing to adhere to the prohibitions and restrictions specified in the protocol
- A man who is sexually active must agree to use a condom; and a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use a condom in combination with an adequate contraception method as deemed appropriate by the investigator (example, double-barrier method, partner using effective contraception [defined as hormonal contraception (pill, patch, injection), intrauterine device, surgical sterilization] and to not donate sperm for 5 months after receiving the study drug
- Body mass index (BMI; weight [kg]/height2 [m]2) between 18 and 30 kilogram per square meter (kg/m2) (inclusive), and body weight not less than 50 kg
Key exclusion criteria (5 listed)
- 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, hepatic or renal insufficiency [creatinine clearance below 90 milliliter per minute (mL/min)], thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- History or current evidence of ophthalmic disorder, such as central serous retinopathy or retinal vein occlusion, active wet age related macular degeneration, diabetic retinopathy with macular edema, uncontrolled glaucoma, corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
- Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) and clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at screening or at admission to the study center as deemed appropriate by the investigator
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before dosing is scheduled until End-of-Study procedures
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and Day -2 of the treatment period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-42756493Participants will receive a single oral solution at a dose of 12 milligram (mg) of unlabeled JNJ--42756493 admixed with 14C- labeled JNJ--42756493. | Drug | JNJ-42756493 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
The Cmax is the maximum observed plasma concentration.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
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.
Apparent Clearance (CL/F)
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Apparent Volume of Distribution (Vd/F)
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after subcutaneous dose (Vd/F) is influenced by the fraction absorbed.
Elimination Rate Constant
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Lambda(z) is first-order elimination 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.
Unbound Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
The Cmax is the maximum observed plasma concentration.
Unbound Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
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.
Amount of Drug Excreted in Urine (Ae)
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
The Ae is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.
Renal Clearance (CLR)
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Renal clearance calculated as Ae/AUC (last).
Area Under First Moment Plasma Concentration-Time Curve (AUMC)
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
AUMC is defined as the area under first moment plasma concentration-time curve from time of dosing up to definite time t, to infinity, or to the time of last measurable concentration determined by the following equation: AUMC(0 to infinity)=Cntn/k elimination(el) + Cn/k(el^2) summation[(tn - tn^-1) (Cn^-1) (tn^-1)] + Cntn/2 where Cn=last quantifiable concentration, tn=time at which Cn is measured, k=rate constant.
Elimination Half-Life Associated With the Terminal Slope
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve, calculated as 0.693/Lamda(z).
Percentage of Drug Excreted in Urine (Ae%dose)
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
The Ae%dose is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.
Amount of Drug Excreted in Urine (Ae) from t1 to t2
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Amount of drug excreted into urine over a given time interval from t1 to t2, where t1 and t2 are the start and end times of the interval.
Percentage of Extrapolated Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (Percentage AUCinfinity, extrapolated [%AUCinf,ex])
Time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14
Percentage of the AUCinfinity obtained by extrapolation calculated by ratio between AUCinfinity minus AUClast versus AUCinfinity.
1 secondary outcome
Number of Participants With Adverse Events
Time frame: Baseline up to follow up (79 to 93 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-42756493 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: Pre-dose,0.5,1,2,3,4,8,12 hour post-dose(pd) on Day 1;24,36 h pd on Day 2;48 h pd on Day 3,72 h pd on Day 4; 96 h pd on Day 5;192 h pd on Day 9,216 h pd on Day 10,240 h pd on Day 11,264 h pd on Day 12,288 h pd on Day 13 and 312 h pd on Day 14). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2017.