The aim of this study is to investigate how quickly and to what extent JNJ-40411813 is absorbed, transported, and eliminated from the body. For this study, JNJ-40411813 is radioactively labelled with carbon-14 (14C). In this way JNJ-40411813 can be…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Concentrations of JNJ-4041183, and metabolites in plasma.
Concentrations of total radioactivity in plasma and whole blood.
Amount of JNJ-40411813, and metabolites in urine.
Amount of total radioactivity in urine and feces (and samples of duodenal
fluid, if feasible).
As required, derived PK parameters of JNJ-40411813, and metabolites, and total
radioactivity.
Secondary outcome
Adverse events (AEs), significant changes in vital signs, ECG, safety
laboratory results, and C-SSRS
Background summary
The study will evaluate the study compound JNJ-40411813, which is being
developed for the treatment of diseases such as epilepsy, anxiety and
schizophrenia.
Study objective
The aim of this study is to investigate how quickly and to what extent
JNJ-40411813 is absorbed, transported, and eliminated from the body. For this
study, JNJ-40411813 is radioactively labelled with carbon-14 (14C). In this way
JNJ-40411813 can be traced in blood, urine, and feces, and in duodenal fluid.
The liquid from the duodenum will be collected via a device called an
EnteroTracker. The radioactivity is not harmful to the health.
We also investigate how safe JNJ-40411813 is and how well it is tolerated when
it is used by healthy men.
Study design
the study takes about 10 weeks from the screening to the follow-up visit.
In total, the volunteer visits the research center a maximum of 5 times:
• once for the screening
• once for a stay in the research center of 16 days (15 nights). Day 1 is the
day on which the research substance is administered. Departure from the
research center is on Day 15 of the study.
• 2 visits of 24 hours (if necessary). If the radioactivity level in stool and
urine has not yet reached predefined criteria on Day 15, the volunteer will
return to the study center for 24-hour visits to collect urine and stool on Day
22 and, if necessary, also on Day 29. Departure is then on Day 23 and Day 30.
• a follow-up visit 8 to 12 days after the last stay in the research center.
the volunteer is given JNJ-40411813 as a 50 milliliter drink by mouth. After
the administration of the study drug, the bottle will be rinsed three times
with 50 ml of water, which the volunteer must also drink. After that, the
volunteer has to drink another 40 ml of water, so that a total of 240 ml has
been ingested.
The volunteer receives the study drug 30 minutes after the start of a
standardized breakfast, which must be started right on time and eaten
completely within 20 minutes.
Intervention
The volunteer receives 14C radiolabelled JNJ-40411813 once, 30 minutes after a
standardized breakfast
Study burden and risks
Blood draw
Drawing blood may be painful or cause some bruising. The use of the indwelling
cannula can sometimes lead to inflammation, swelling, hardening of the vein,
blood clotting, and bleeding in the environment of the puncture site. In some
individuals, a blood draw can sometimes cause pallor, nausea, sweating, low
heart rate, or drop in blood pressure with dizziness or fainting.
In total, we will take about 487.7 milliliters (mL) of blood from you from
screening to follow-up. This amount does not cause any problems in adults. To
compare: a blood donation involves 500 mL of blood being taken each time at
once. If the investigator thinks it is necessary for the safety of a subject,
extra samples might be taken for possible additional testing. If this happens,
the total amount of blood drawn may be more than the amount indicated above.
Heart tracing
To make a heart tracing, electrodes (small, plastic patches) will be placed on
your arms, chest and legs. Prolonged use of these electrodes can cause skin
irritation (rash and itching).
Coronavirus test
Samples for the coronavirus test will be taken from the back of your nose and
throat using swabs. Taking the samples only takes a few seconds, but can cause
discomfort and can give an unpleasant feeling. Taking a sample from the back of
your throat may cause you to gag. When the sample is taken from the back of
your nose, you may experience a stinging sensation and your eyes may become
watery.
Graaf Engelbertlaan 75
Breda 4837 DS
NL
Graaf Engelbertlaan 75
Breda 4837 DS
NL
Listed location countries
Age
Inclusion criteria
1. Age: 18 (or the legal age of consent in the jurisdiction in which the study
is taking place) to 55 years of age, inclusive.
2. Healthy on the basis of physical examination, medical history, vital signs,
and 12-lead ECG performed at screening. If there are any abnormalities, they
must be considered not clinically relevant, and this determination must be
recorded in the participant's source documents and initialed by the
investigator.
3. Healthy on the basis of clinical laboratory tests performed at screening. If
the results of the serum chemistry panel, hematology, coagulation, or
urinalysis are outside the normal reference ranges, the participant may be
included only if the investigator judges the abnormalities or deviations from
normal to be not clinically significant or to be appropriate and reasonable for
the population under study. This determination must be recorded in the
participant's source documents and initialed by the investigator.
4. Blood pressure (after the participant is supine for 5 minutes) between 90
mm and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic at
screening. If blood pressure is out of range, up to 2 repeated assessments are
permitted.
5. Must not have current COVID-19 infection, confirmed by SARS-CoV-2 polymerase
chain reaction (PCR), on Day -1.
6. Weight : Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body
weight not less than 50.0 kg.
Further criteria apply
Exclusion criteria
1. 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
insufficiency, impaired hepatobiliary function (gall bladder removed, has a
hepatobiliary shunt, etc), 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.
*Participants with childhood asthma that resolved by the age of 12 years are
eligible.
**Participants with a history of a suicidal attempt at any time in the past, or
suicidal ideation within the past year, as measured by the Columbia-Suicide
Severity Rating Scale (C-SSRS) baseline/screening version are excluded.
2. Participant has ALT or aspartate aminotransferase values >=1.5x the upper
limit of normal (ULN) or total bilirubin >1.5 times the ULN at screening.
3. Creatinine clearance <=61 mL/min based on Chronic Kidney Disease
Epidemiology Collaboration formula at screening.
4. 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, which is considered cured with minimal risk of
recurrence).
5. History of stomach or intestinal surgery or resection, including
cholecystectomy, that would potentially alter absorption or excretion of orally
administered drug (appendectomy and hernia repair will be allowed).
Further criteria apply
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 40411813EDI1013 |
| EudraCT | EUCTR2022-002405-20-NL |
| CCMO | NL82169.056.22 |