A Phase 1, Open-Label Study in Healthy Adult Participants to Assess the Pharmacokinetics of JNJ-64281802 Administered as Different Multiple Dose Regimens

Completed

• Conditions: Dengue; 10047438

• Registration Number: NL-OMON51387
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2023-11-23
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the PK of JNJ-64281802 in healthy participants when administered in<br /><br>different multiple dose regimens and as different dose strengths.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the safety and tolerability of JNJ-64281802 in healthy participants<br /><br>when administered in different multiple dose regimens and as different dose<br /><br>strengths.</p><br>