HealthyPhase 1NCT03025022
A Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of 14C-JNJ-42847922 After a Single Oral Dose of 40 mg in Healthy Subjects
A Phase 1 study testing 14C-JNJ-42847922 40 mg in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The objective of this study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of 14C-JNJ-42847922 in healthy subjects after a single oral dose of 40 milligram (mg) 14C-JNJ-42847922 containing maximally 100 MicroCurie. Safety and tolerability will also be assessed. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 14C-JNJ-42847922 40 mg
- 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
- 17 Jan 2017to 27 Feb 2017
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed an informed consent document indicating they (healthy participants) understand the purpose of and procedures required for the study and are willing to participate in the study
- Willing to adhere to the prohibitions and restrictions specified in the protocol
- Women may be eligible to participate if they are of non child-bearing potential, which is defined as (a) Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level (more than [>] 40 International Units Per Litre [IU/L] or milli-International Units per milliliter [mIU/mL]) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; OR (b) Permanently Sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy
- Body mass index (BMI; weight kilogram [kg]/height^2 (meter [m]^2)) between 18 and 30 kilogram per meter square (kg/m^2) (inclusive), and body weight not less than 50 kg (kilogram)
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of Merury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening and on Day -1
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, including: Sinus rhythm, Pulse rate between 45 and 90 beats per minute (bpm), corrected QT (QTc) interval less than and equal to (<=) 450 millisecond (msec), QRS interval of <110 msec, PR interval less than (<) 200 msec. Morphology consistent with healthy cardiac conduction and function.
- During the study and for a minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study drug, in addition to the user independent highly effective method of contraception, a man who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (example [e.g.], condom with spermicidal foam/gel/film/cream/suppository) or must agree not to donate sperm, who is pregnant must use a condom.
- Non-tobacco user (nicotine substances, including tobacco products (e.g., cigarettes, e-cigarettes, cigars, chewing tobacco, gum or patch) (current and for past 6 months prior to screening)
Who cannot join
- Exposure to significant radiation for professional or medical reasons except dental x-rays (example, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to dosing. Exposure to X-rays of thorax and bone skeleton, (excluding spinal column) in the past 12 months
- Participants cannot have participated in a radiolabelled drug study for 12 months prior to dosing
- 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), syncope, hypotension, hypertension or vascular disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 60 milliLiter per minute (mL/min), kidney or urinary tract disturbances, thyroid disease, neurologic disease, significant psychiatric disorder, epilepsy, or fits of unexplained black-outs, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, that in the opinion of the investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence)
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis 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 (325 milligram [mg]), within 14 days before the first dose of the study drug is scheduled until completion of the study
Show all 22Show fewer
- Received a known inhibitor of cytochrome P450 (CYP) 3A4 or CYP2C9 activity within 28 days or a period less than 5 times the drug's half life (t1/2), whichever is longer, before the dose of the study drug is scheduled until completion of the study
- Received a known inducer of CYP3A4 or CYP2C9 activity within 28 days before the dose of study drug is scheduled until completion of the study
- Consumption of grapefruit products within 28 days before the first dose of the study drug is scheduled until completion of the study
- Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half life (t1/2), whichever is longer, before the dose of the study drug is scheduled
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 1 year before screening or positive test result(s) for alcohol, cotinine, and/or drugs of abuse (such as hallucinogens, barbiturates, opiates, opioids, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and Day -1 of the treatment period
- Known allergy to the study drug or any of the excipients of the formulation
- Donated blood or blood products or had substantial loss of blood (more than 500 milliLitre [mL]) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
- If a man, who plans to father a child while enrolled in the study or for 3 months after receiving the last dose of study drug
- Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
- Regular use of tobacco or nicotine containing products in the past 6 months, as determined by medical history or participant's verbal report
- Positive test result(s) for nicotine at screening or Day -1 of the treatment period
- Recent changes in bowel habits (frequency, consistency, and amount) and irregular defecation pattern (less than one defecation per day)
- Preplanned surgery or procedures that would interfere with the conduct of the study
- Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator or employees of Johnson \& Johnson
- Any participant who, in the opinion of the Investigator, should not participate in this study
- Has suicidal ideation with some intent to act, as per Columbia Suicide Severity Rating Scale (C-SSRS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of 14C-JNJ-42847922 After a Single Oral Dose of 40 mg in Healthy Subjects
The objective of this study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of 14C-JNJ-42847922 in healthy subjects after a single oral dose of 40 milligram (mg) 14C-JNJ-42847922 containing maximally 100 MicroCurie. Safety and tolerability will also be assessed.
- Conditions
- Healthy
- Being tested
- 14C-JNJ-42847922 40 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-JNJ-42847922 40 mgDrug
Participants will receive a single 40 mg oral dose of 14C-JNJ-42847922 containing maximally 100 MicroCurie as a 40 milliLitre (mL) solution.
| Study group | Role | What they receive |
|---|---|---|
| 14C-JNJ-42847922 40 miiligram (mg) | Experimental | Participants will receive a single 40 mg oral dose of 14C-JNJ-42847922 on Day 1. Receives: Drug: 14C-JNJ-42847922 40 mg |
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: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Measured: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
Time to Last Observed Quantifiable Concentration (T[last])
The T(last) is the time to last observed quantifiable concentration.
Measured: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
Area Under the Curve From Time Zero to End of Dosing Interval (AUC[last])
The AUC(last) is the measure of the plasma drug concentration from time zero to time of the last observed quantifiable concentration.
Measured: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
The 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, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Measured: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
Percent of AUC(0-infinity) Extrapolated (%AUC_extrap)
The %AUC_extrap is the percentage of AUC(0-infinity) accounted for by extrapolation. It is calculated as (AUC [infinity] minus [-] AUC[last])*100/ AUC[infinity], where AUC[infinity] is area under the plasma concentration versus time curve from time zero to extrapolated infinite time and AUC(last) is area under the plasma concentration time-curve from zero to the last measured concentration.
Measured: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
Elimination Half-Life (t[1/2])
The elimination half-life (t[1/2]) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Measured: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
Elimination Rate Constant (Lambda [z])
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: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
Apparent Total 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: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
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 plasma concentration of a drug. Apparent volume of distribution after oral dose (Vd/F) is influenced by the fraction absorbed.
Measured: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
Amount of Drug Excreted in Urine (Ae)
Ae refers to the total amount of drug excreted in urine.
Measured: Up to Day 14
Percentage of Drug Excreted in Urine (%Ae)
The %Ae is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.
Measured: Up to Day 14
Renal Clearance (CLr)
The CLr is the renal clearance of the drug, calculated as Ae/AUC(0-infinity).
Measured: Up to Day 14
Amount of Drug Excreted in Feces (Fe)
The Fe refers to the total amount of drug excreted in feces.
Measured: Up to Day 14
Percentage of Drug Excreted in Feces (%Fe)
The %Fe is the total amount excreted in feces, expressed as a percentage of the administered dose.
Measured: Up to Day 14
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Measured: From Screening to End of study (Approximately up to 46 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start17 Jan 2017
- Primary completion27 Feb 2017
- Study completion27 Feb 2017
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
- Other
- 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
- NCT03025022
- Sponsor's protocol ID
- CR108268
- Other IDs
- 42847922EDI1008
- Status last verified
- May 2017
- First submitted
- 17 Jan 2017
- Last updated
- 10 May 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 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of 14C-JNJ-42847922 After a Single Oral Dose of 40 mg in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03025022
- Acronym / sponsor ID
- CR108268
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 19 Jan 2017 (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 objective of this study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of 14C-JNJ-42847922 in healthy subjects after a single oral dose of 40 milligram (mg) 14C-JNJ-42847922 containing maximally 100 MicroCurie. Safety and tolerability will also be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C-JNJ-42847922 40 miiligram (mg) | Experimental | Drug: 14C-JNJ-42847922 40 mgParticipants will receive a single 40 mg oral dose of 14C-JNJ-42847922 on Day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed an informed consent document indicating they (healthy participants) understand the purpose of and procedures required for the study and are willing to participate in the study
- Willing to adhere to the prohibitions and restrictions specified in the protocol
- Women may be eligible to participate if they are of non child-bearing potential, which is defined as (a) Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level (more than [>] 40 International Units Per Litre [IU/L] or milli-International Units per milliliter [mIU/mL]) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; OR (b) Permanently Sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy
- Body mass index (BMI; weight kilogram [kg]/height^2 (meter [m]^2)) between 18 and 30 kilogram per meter square (kg/m^2) (inclusive), and body weight not less than 50 kg (kilogram)
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of Merury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening and on Day -1
Key exclusion criteria (22 listed)
- Exposure to significant radiation for professional or medical reasons except dental x-rays (example, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to dosing. Exposure to X-rays of thorax and bone skeleton, (excluding spinal column) in the past 12 months
- Participants cannot have participated in a radiolabelled drug study for 12 months prior to dosing
- 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), syncope, hypotension, hypertension or vascular disorders, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 60 milliLiter per minute (mL/min), kidney or urinary tract disturbances, thyroid disease, neurologic disease, significant psychiatric disorder, epilepsy, or fits of unexplained black-outs, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, that in the opinion of the investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence)
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
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 |
|---|---|---|
| 14C-JNJ-42847922 40 mgParticipants will receive a single 40 mg oral dose of 14C-JNJ-42847922 containing maximally 100 MicroCurie as a 40 milliLitre (mL) solution. | Drug | 14C-JNJ-42847922 40 miiligram (mg) |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
The Cmax is the maximum observed plasma concentration.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Time to Last Observed Quantifiable Concentration (T[last])
Time frame: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
The T(last) is the time to last observed quantifiable concentration.
Area Under the Curve From Time Zero to End of Dosing Interval (AUC[last])
Time frame: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
The AUC(last) is the measure of the plasma drug concentration from time zero to time of the last observed quantifiable concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Time frame: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
The 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, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Percent of AUC(0-infinity) Extrapolated (%AUC_extrap)
Time frame: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
The %AUC_extrap is the percentage of AUC(0-infinity) accounted for by extrapolation. It is calculated as (AUC [infinity] minus [-] AUC[last])*100/ AUC[infinity], where AUC[infinity] is area under the plasma concentration versus time curve from time zero to extrapolated infinite time and AUC(last) is area under the plasma concentration time-curve from zero to the last measured concentration.
Elimination Half-Life (t[1/2])
Time frame: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
The elimination half-life (t[1/2]) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Elimination Rate Constant (Lambda [z])
Time frame: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
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.
Apparent Total Clearance (CL/F)
Time frame: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
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: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose
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 plasma concentration of a drug. Apparent volume of distribution after oral dose (Vd/F) is influenced by the fraction absorbed.
Amount of Drug Excreted in Urine (Ae)
Time frame: Up to Day 14
Ae refers to the total amount of drug excreted in urine.
Percentage of Drug Excreted in Urine (%Ae)
Time frame: Up to Day 14
The %Ae is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.
Renal Clearance (CLr)
Time frame: Up to Day 14
The CLr is the renal clearance of the drug, calculated as Ae/AUC(0-infinity).
Amount of Drug Excreted in Feces (Fe)
Time frame: Up to Day 14
The Fe refers to the total amount of drug excreted in feces.
Percentage of Drug Excreted in Feces (%Fe)
Time frame: Up to Day 14
The %Fe is the total amount excreted in feces, expressed as a percentage of the administered dose.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: From Screening to End of study (Approximately up to 46 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 10 May 2017.
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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 14C-JNJ-42847922 40 mg 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 8 inclusion and 22 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 10 May 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: Predose (-0.5 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 32, 36, 48, 54, 60, and 72 hours postdose). 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 10 May 2017.