A Study of JNJ-64281802 in Healthy Adult Participants
- Registration Number
- NCT05201937
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Panel 1 (JNJ-64281802 High Dose Regimen) JNJ-64281802 Participants will receive Loading Dose (LD) 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by maintenance Dose (MD) 1 of JNJ-64281802 once daily on Days 3, 10, 17 and 24. Arm A: Panel 2 (JNJ-64281802 High Dose Regimen) JNJ-64281802 Participants will receive LD 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 2 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27. Arm C: Panel 5 (JNJ-64281802 [Optional]) JNJ-64281802 Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B. Arm C: Panel 6 (JNJ-64281802 [Optional]) JNJ-64281802 Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B. Arm B: Panel 3 (JNJ-64281802 Low Dose Regimen) JNJ-64281802 Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 3 of JNJ-64281802 once daily on Days 3, 10, 17 and 24. Arm B: Panel 4 (JNJ-64281802 Low Dose Regimen) JNJ-64281802 Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 4 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27.
- Primary Outcome Measures
Name Time Method Observed Plasma Concentration of JNJ-64281802 Just Prior to the Beginning of a Dosing Interval (Ctrough) Up to Day 62 Ctrough is defined as observed plasma concentration of JNJ-64281802 just prior to the beginning of a dosing interval.
Maximum Observed Plasma Concentration (Cmax) of JNJ-64281802 Up to Day 62 Cmax is defined as maximum observed plasma concentration of JNJ-64281802.
Apparent Terminal Elimination Half-life (t1/2) of JNJ-64281802 Up to Day 62 t1/2 is defined as apparent terminal elimination half-life of JNJ-64281802.
Area Under the Curve From Time Zero to tau (AUC[0-tau]) of JNJ-64281802 Up to Day 62 AUC(0-tau) is defined as area under the curve from time 0 to tau hours post dose of JNJ-64281802.
Total Apparent Oral Clearance (CL/F) of JNJ-64281802 Up to Day 62 CL/F is defined as total apparent oral clearance of JNJ-64281802.
Area Under the Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of JNJ-64281802 Up to Day 62 AUC(0-last) is defined as area under the curve from time 0 to the time of the last measurable concentration of JNJ-64281802.
Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of JNJ-64281802 Up to Day 62 AUC(0-inf) is defined as area under the curve of JNJ-64281802 from time 0 to infinity time.
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-64281802 Up to Day 62 Tmax is defined the actual sampling time to reach the maximum observed plasma concentration of JNJ-64281802.
- Secondary Outcome Measures
Name Time Method Number of Participants with Abnormalities in Clinical Laboratory Tests Up to 62 days Number of participants with abnormalities in clinical laboratory tests (including hematology, serum chemistry and urinalysis) will be reported.
Number of Participants with Adverse Events (AEs) Up to 62 days An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with Abnormalities in 12-lead Electrocardiograms (ECGs) Up to 62 days Number of participants with abnormalities in 12-lead ECGs will be reported.
Number of Participants with Abnormalities in Physical Examinations Up to 62 days Number of participants with abnormalities in physical examinations (including skin examination, height and body weight) will be reported.
Number of Participants with Abnormalities in Vital Sign Measurements Up to 62 days Number of participants with abnormalities in vital sign measurements (including temperature, temporal artery measurements, pulse/heart rate and blood pressure) will be reported.
Trial Locations
- Locations (1)
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
🇳🇱Groningen, Netherlands