Clinical trial NCT05201937: A Study of JNJ-64281802 in Healthy Adult Participants
Official title: A Phase 1, Open-Label Study in Healthy Adult Participants to Assess the Pharmacokinetics of JNJ-64281802 Administered as Different Multiple Dose Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-01-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-64281802 in healthy participants when administered in different multiple dose regimens and as different dose strengths.


Eligibility criteria: Inclusion Criteria:

* 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
* Body weight not less than 50 kilogram (kg) and body mass index (BMI) within the range 18.0 and 30.0 kilogram per meter square (kg/m\^2), extremes included, at screening and Day -1
* All women must have a negative highly sensitive serum (beta human chorionic gonadotropin \[beta hCG\]) at screening and a negative urine pregnancy test at Day -1
* Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
* Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study, before starting any screening activities

Exclusion Criteria:

* Any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
* Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients
* Has been dosed with JNJ-64281802 in past 3 months
* Current human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) infection (confirmed by antibodies) at screening
* Current Coronavirus disease 2019 (COVID-19) infection (confirmed by severe acute respiratory syndrome coronavirus 2 \[SARS-CoV2\] polymerase chain reaction \[PCR\]) at the time of admission to the study site (Day -1)

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-64281802
timeFrame: Up to Day 62
measure: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-64281802
timeFrame: Up to Day 62
measure: Observed Plasma Concentration of JNJ-64281802 Just Prior to the Beginning of a Dosing Interval (Ctrough)
timeFrame: Up to Day 62
measure: Apparent Terminal Elimination Half-life (t1/2) of JNJ-64281802
timeFrame: Up to Day 62
measure: Area Under the Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of JNJ-64281802
timeFrame: Up to Day 62
measure: Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of JNJ-64281802
timeFrame: Up to Day 62
measure: Area Under the Curve From Time Zero to tau (AUC[0-tau]) of JNJ-64281802
timeFrame: Up to Day 62
measure: Total Apparent Oral Clearance (CL/F) of JNJ-64281802
timeFrame: Up to Day 62
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 62 days
measure: Number of Participants with Abnormalities in 12-lead Electrocardiograms (ECGs)
timeFrame: Up to 62 days
measure: Number of Participants with Abnormalities in Physical Examinations
timeFrame: Up to 62 days
measure: Number of Participants with Abnormalities in Vital Sign Measurements
timeFrame: Up to 62 days
measure: Number of Participants with Abnormalities in Clinical Laboratory Tests
timeFrame: Up to 62 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: