HealthyPhase 1NCT03002779
A Study to Characterize the Absorption, Metabolism, and Excretion of 14C-JNJ-53718678 After a Single Oral Dose in Healthy Male Participants
A Phase 1 study testing JNJ-53718678 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
Trial summary
The purpose of the study is to determine the routes of excretion for JNJ-53718678 and its metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the chemical structure of predominant metabolites in healthy adult male participants after a single oral dose of 500 milligram (mg) 14C-JNJ-53718678. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-53718678
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Jan 2017to 20 Mar 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A male participant: a) Must be sexually abstinent (defined as refraining from sexual intercourse from Day 1 (day of dosing) until 90 days after study drug administration), OR b) Who is sexually active (either heterosexual, including with a pregnant woman, or homosexual) must agree to use a barrier method of contraception (eg, condom) from Day 1 (day of dosing) until 90 days after study drug administration, AND c) Who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (eg, condom) from Day 1 (day of dosing) until 90 days after study drug administration, in conjunction with this female partner using a highly effective contraceptive (such as implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system, combined [estrogen- and progestogen- containing] hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal; progestogen-only hormone contraception associated with inhibition of ovulation: oral or injectable) d) Must agree not to donate sperm from Day 1 (day of dosing) until 90 days after study drug administration
- Participant must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m^2)
- Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
- Participant must have a normal 12-lead electrocardiogram (ECG) (based on the mean value of triplicate ECG parameters), consistent with normal cardiac conduction and function at screening, including: a) normal sinus rhythm (heart rate between 45 and 90 beats per minute (bpm), extremes included); b)mean QT interval corrected for heart rate according to Fridericia formula (QTcF) interval lesser than or equal to (<=)450 millisecond (ms); c) mean QRS interval of <110 ms; d) mean PR interval <200 ms; e) morphology consistent with healthy cardiac conduction and function
- Participants must be healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination (including height and body weight measurement and skin examination), medical history, vital signs (systolic and diastolic blood pressure, pulse rate, orthostatic blood pressure changes, respiratory rate, and body temperature), creatinine clearance (below 60 milliliter per minute (mL/min) at screening using Cockroft-Gault equation), and the results of blood biochemistry, blood coagulation, and hematology tests, and a urinalysis performed at screening, on Day -1, or predose on Day 1, whichever is applicable. If there are abnormalities, with the exception of those described in the in- and exclusion criteria, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
Who cannot join
- Participants with a removed gallbladder, or with a history of upper gastrointestinal (stomach, duodenum) surgery, or with a recent (less than 3 months prior to screening) episode of gallbladder stones
- Participants with a history of heart arrhythmias (extrasystoles, tachycardia at rest) or history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT syndrome)
- Participant has intolerance to xylocaine, lactose, or midazolam
- Participant has a history of hepatitis A antibody immunoglobulin M (IgM), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for hepatitis A antibody IgM, HBsAg or anti HCV at screening
- Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, 9728 NZ
About this study
Official title: A Phase 1, Open Label Study to Characterize the Absorption, Metabolism and Excretion of 14C-JNJ-53718678 After a Single Dose in Healthy Adult Male Subjects
The purpose of the study is to determine the routes of excretion for JNJ-53718678 and its metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the chemical structure of predominant metabolites in healthy adult male participants after a single oral dose of 500 milligram (mg) 14C-JNJ-53718678.
- Conditions
- Healthy
- Being tested
- JNJ-53718678
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-53718678Drug
Participants will receive a single 500 milligram (mg) dose of 14C-JNJ-53718678 as an oral liquid solution containing 14C-labeled and unlabeled JNJ-53718678 corresponding to a radioactivity dose.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-53718678 | Experimental | Not described Receives: Drug: JNJ-53718678 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance of JNJ-53718678 in Healthy Adult Male Participants.
Total mass balance calculated by D(dose) urine, total (percent [%]) + D feces, total (%) + D duodenal, total (%) where D urine, total is the total percentage of the dose excreted into urine, calculated as 100 * (Ae total [total amount excreted into urine, calculated by adding the amounts of the individual intervals together] /Dose); D feces,total is the total percentage of the dose excreted into feces, calculated as 100 * (Ae total [total amount excreted into feces, calculated by adding the amounts of the individual stools together]/Dose) and D duodenal, total is defined as total percentage of the dose collected in all duodenal samples collectively, calculated as % of dose.
Measured: Up to Day 10
Metabolic profiles of JNJ-53718678 in plasma, duodenal fluid, urine, and feces samples with radio high-performance liquid chromatography analysis
Metabolite profiling will be performed with radio high-performance liquid chromatography.
Measured: Up to Day 6
Secondary outcomes (1)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Safety and Tolerability
Measured: Throughout the study duration (up to 24 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study start26 Jan 2017
- Primary completion10 Mar 2017
- Study completion20 Mar 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT03002779
- Sponsor's protocol ID
- CR108210
- Other IDs
- 53718678RSV1008, 2016-002664-14, 2016
- Status last verified
- May 2017
- First submitted
- 30 Nov 2016
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label Study to Characterize the Absorption, Metabolism and Excretion of 14C-JNJ-53718678 After a Single Dose in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT03002779
- Acronym / sponsor ID
- CR108210
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 26 Dec 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 the study is to determine the routes of excretion for JNJ-53718678 and its metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the chemical structure of predominant metabolites in healthy adult male participants after a single oral dose of 500 milligram (mg) 14C-JNJ-53718678.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JNJ-53718678 | Experimental | Drug: JNJ-53718678 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A male participant: a) Must be sexually abstinent (defined as refraining from sexual intercourse from Day 1 (day of dosing) until 90 days after study drug administration), OR b) Who is sexually active (either heterosexual, including with a pregnant woman, or homosexual) must agree to use a barrier method of contraception (eg, condom) from Day 1 (day of dosing) until 90 days after study drug administration, AND c) Who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (eg, condom) from Day 1 (day of dosing) until 90 days after study drug administration, in conjunction with this female partner using a highly effective contraceptive (such as implantable progestogen-only hormone contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system, combined [estrogen- and progestogen- containing] hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal; progestogen-only hormone contraception associated with inhibition of ovulation: oral or injectable) d) Must agree not to donate sperm from Day 1 (day of dosing) until 90 days after study drug administration
- Participant must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m^2)
- Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
- Participant must have a normal 12-lead electrocardiogram (ECG) (based on the mean value of triplicate ECG parameters), consistent with normal cardiac conduction and function at screening, including: a) normal sinus rhythm (heart rate between 45 and 90 beats per minute (bpm), extremes included); b)mean QT interval corrected for heart rate according to Fridericia formula (QTcF) interval lesser than or equal to (<=)450 millisecond (ms); c) mean QRS interval of <110 ms; d) mean PR interval <200 ms; e) morphology consistent with healthy cardiac conduction and function
- Participants must be healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination (including height and body weight measurement and skin examination), medical history, vital signs (systolic and diastolic blood pressure, pulse rate, orthostatic blood pressure changes, respiratory rate, and body temperature), creatinine clearance (below 60 milliliter per minute (mL/min) at screening using Cockroft-Gault equation), and the results of blood biochemistry, blood coagulation, and hematology tests, and a urinalysis performed at screening, on Day -1, or predose on Day 1, whichever is applicable. If there are abnormalities, with the exception of those described in the in- and exclusion criteria, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
Key exclusion criteria (5 listed)
- Participants with a removed gallbladder, or with a history of upper gastrointestinal (stomach, duodenum) surgery, or with a recent (less than 3 months prior to screening) episode of gallbladder stones
- Participants with a history of heart arrhythmias (extrasystoles, tachycardia at rest) or history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT syndrome)
- Participant has intolerance to xylocaine, lactose, or midazolam
- Participant has a history of hepatitis A antibody immunoglobulin M (IgM), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for hepatitis A antibody IgM, HBsAg or anti HCV at screening
- Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
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-53718678Participants will receive a single 500 milligram (mg) dose of 14C-JNJ-53718678 as an oral liquid solution containing 14C-labeled and unlabeled JNJ-53718678 corresponding to a radioactivity dose. | Drug | JNJ-53718678 |
Primary outcome
Mass Balance of JNJ-53718678 in Healthy Adult Male Participants.
Time frame: Up to Day 10
Total mass balance calculated by D(dose) urine, total (percent [%]) + D feces, total (%) + D duodenal, total (%) where D urine, total is the total percentage of the dose excreted into urine, calculated as 100 * (Ae total [total amount excreted into urine, calculated by adding the amounts of the individual intervals together] /Dose); D feces,total is the total percentage of the dose excreted into feces, calculated as 100 * (Ae total [total amount excreted into feces, calculated by adding the amounts of the individual stools together]/Dose) and D duodenal, total is defined as total percentage of the dose collected in all duodenal samples collectively, calculated as % of dose.
Metabolic profiles of JNJ-53718678 in plasma, duodenal fluid, urine, and feces samples with radio high-performance liquid chromatography analysis
Time frame: Up to Day 6
Metabolite profiling will be performed with radio high-performance liquid chromatography.
1 secondary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Throughout the study duration (up to 24 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 31 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 JNJ-53718678 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
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 5 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 31 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 Netherlands. 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?
Mass Balance of JNJ-53718678 in Healthy Adult Male Participants. (time frame: Up to Day 10). The study lists 2 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 31 May 2017.