In this study we will compare different dosing regimens with the study compound JNJ-64281802. We investigate how quickly and to what extent different doses JNJ-64281802 are absorbed, transported, and eliminated from the body when they are given at…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the PK of JNJ-64281802 in healthy participants when administered in
different multiple dose regimens and as different dose strengths.
Secondary outcome
To assess the safety and tolerability of JNJ-64281802 in healthy participants
when administered in different multiple dose regimens and as different dose
strengths.
Background summary
JNJ-64281802 is a new compound that may potentially be used for the treatment
of dengue. Dengue (or dengue fever) is caused by the dengue virus, which is
transmitted by mosquito bites. Dengue was almost eradicated in the 1970s, but
has now spread to more than 125 countries. On average, each year about 500,000
dengue cases require hospitalization due to severe and life-threatening disease
and up to 25,000 patients die due to dengue. JNJ 64281802 is currently being
evaluated for the prevention and treatment of dengue infection, as it can
inhibit the replication of the virus.
Study objective
In this study we will compare different dosing regimens with the study compound
JNJ-64281802. We investigate how quickly and to what extent different doses
JNJ-64281802 are absorbed, transported, and eliminated from the body when they
are given at different time intervals. We also look how safe JNJ 64281802 is
and how well it is tolerated when it is used by healthy participants.
In treatment group 1, a device called TASSO-M20 will be used to draw blood in
addition to regular blood draw. TASSO-M20 is a new device that should make it
easier for patients to take samples of their own blood in the future. The blood
concentrations of JNJ-64281802 measured in blood samples taken with the TASSO
M20 device will be compared to the concentrations in the samples that are taken
by direct puncture of a blood vessel. Subjects will use the device themselves,
and they also have to take blood samples with this device themselves while they
are at home.
We also look at the effect of genetic information on the body*s response to
JNJ-64281802. This part of the study is mandatory.
JNJ-64281802 has been used by humans before. In addition, it has been
extensively tested in the laboratory and on animals.
Study design
Group 1 and 3
Screening -> Day -28 to -2
Stay 1 -> Day -1 to 6
Stay 2 -> Day 9 to 11
Stay 3 -> Day 16 to 18
Stay 4 -> Day 23 to 29
Videocall (group 1 only) -> Day 30
Visit 1 -> Day 31
Visit 2 -> Day 38
Videocall (group 1 only) -> Day 40
Visit 3 -> Day 45
Visit 4 -> Day 51
Follow-up -> Day 59
Group 2 and 4
Screening -> Day -28 to -2
Stay 1 -> Day -1 to 7
Stay 2 -> Day 9 to 11
Stay 3 -> Day 12 to 14
Stay 4 -> Day 16 to 18
Stay 5 -> Day 19 to 21
Stay 6 -> Day 23 to 25
Stay 7 -> Day 26 to 29
Visit 1 -> Day 29
Visit 2 -> Day 30
Visit 3 -> Day 31
Visit 4 -> Day 34
Visit 5 -> Day 41
Visit 6 -> Day 48
Visit 7 -> Day 54
Follow-up -> Day 62
JNJ-64281802 with water
Intervention
Group 1 and 3:
Medication on Day 1, 2, 3, 10, 17 and 24
Group 2 and 4:
Medication on Day 1, 2, 3, 6, 10, 13, 17, 20, 24 and 27
Study burden and risks
Blood draw
Drawing blood may be painful or cause some bruising. The use of the indwelling
cannula (a tube in a vein in the arm) can sometimes lead to inflammation,
swelling, hardening of the vein, blood clotting, and bleeding in the
environment (bruising) 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 not take more than 350 milliliters (mL) of blood 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
participant, 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
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 the 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
the throat may cause subjects to gag. When the sample is taken from the back of
the nose, they may experience a stinging sensation and the eyes may become
watery.
TASSO-M20 device (treatment group 1 only)
Minor bruising may occur around the sample collection site while using the
TASSO-M20 device. Subjects will be seated while using the device. In total, we
will take about 2.55 mL of blood with the TASSO-M20 device. In some
individuals, a blood draw can sometimes cause pallor, nausea, sweating, low
heart rate, or drop in blood pressure with dizziness or fainting. Drawing blood
may be painful.
Turnhoutseweg 30
Beerse 2340
BE
Turnhoutseweg 30
Beerse 2340
BE
Listed location countries
Age
Inclusion criteria
1. 18 to 55 years of age, extremes included, at the time of screening.
2. Healthy on the basis of physical examination, medical history (at screening
only), and vital signs performed at screening and Day -1. If
there are abnormalities, the participant may be included only if the
investigator judges the abnormalities 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.
3. Healthy on the basis of clinical laboratory tests performed at screening and
Day -1. If the results of the serum chemistry panel, blood
coagulation, hematology, or urinalysis are outside the normal reference ranges
(except for those listed in the exclusion criteria), the
participantmay 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.
4. Body weight not less than 50 kg and body mass index (BMI; weight kg/height^2
m^2) within the range 18.0 and 30.0 kg/m^2, extremes
included, at screening and Day -1.
5. Man or woman
Exclusion criteria
1. History of or current clinically significant medical illness including (but
not limited to) cardiac arrhythmias (eg, extrasystole, tachycardia at rest) or
other cardiac disease, risk factors for Torsade de Pointes syndrome (eg,
hypokalemia, family history of long QT Syndrome), 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 60 mL/min at
screening, calculated by the Modification of Diet in Renal Disease [MDRD]
formula, vascular, gastrointestinal (such as significant diarrhea, gastric
stasis, or constipation that in the investigator's opinion could influence drug
absorption or bioavailability), rheumatologic, neoplastic, endocrine, thyroid
disease, neurologic or psychiatric disease, infection, metabolic disturbances,
or any other illness that the investigator
considers should exclude the participant or that could interfere with the
interpretation of the study results.
2. Participants with one or more of the following laboratory abnormalities at
screening, as defined by the World Health Organization (WHO) Toxicity Grading
Scale and in accordance with the normal ranges of the clinical laboratory if no
gradings are available:
- Serum creatinine elevation Grade 1 or greater (>=1.1×upper limit of normal
[ULN])
- Hemoglobin lowering Grade 1 or greater (<=10.5 g/dL)
- Platelets count lowering Grade 1 or greater (<=99,000/mm³)
- Absolute neutrophil count lowering Grade 1 or greater (<=1,500/mm³)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation
Grade 1 or greater (>=1.25 ×ULN)
- Total bilirubin Grade 1 or greater (>=1.1 ×ULN)
- Any other laboratory toxicity Grade 2 or greater (for elevations of
triglycerides, low-density lipoprotein (LDL) cholesterol, and/or total
cholesterol: Grade 3 or greater).
3. Any history of clinically significant skin disease such as, but not limited
to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria.
4. Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its
excipients.
5. Has been dosed with JNJ-64281802 in past 3 months.
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 |
|---|---|
| EudraCT | EUCTR2021-005574-25-NL |
| CCMO | NL80079.056.22 |