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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Netherlands

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 groups in NCT03002779
Study groupRoleWhat they receive
JNJ-53718678ExperimentalNot described
Receives: Drug: JNJ-53718678

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)
  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.

  1. First posted26 Dec 2016 (estimated)
  2. Study start26 Jan 2017
  3. Primary completion10 Mar 2017
  4. Study completion20 Mar 2017

Resources

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)
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

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.

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