A Study of JNJ-64281802 in Healthy Adult Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05201937
• Other study ID #: CR109139
• Secondary ID: 2021-005574-2564
• Status: Completed
• Phase: Phase 1
• Start date: February 23, 2022
• Est. completion date: December 11, 2022

Study information

• Verified date: April 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 11, 2022
• Est. primary completion date: December 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of JNJ-64281802	Cmax is defined as maximum observed plasma concentration of JNJ-64281802.	Up to Day 62
Primary	Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-64281802	Tmax is defined the actual sampling time to reach the maximum observed plasma concentration of JNJ-64281802.	Up to Day 62
Primary	Observed Plasma Concentration of JNJ-64281802 Just Prior to the Beginning of a Dosing Interval (Ctrough)	Ctrough is defined as observed plasma concentration of JNJ-64281802 just prior to the beginning of a dosing interval.	Up to Day 62
Primary	Apparent Terminal Elimination Half-life (t1/2) of JNJ-64281802	t1/2 is defined as apparent terminal elimination half-life of JNJ-64281802.	Up to Day 62
Primary	Area Under the Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of JNJ-64281802	AUC(0-last) is defined as area under the curve from time 0 to the time of the last measurable concentration of JNJ-64281802.	Up to Day 62
Primary	Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of JNJ-64281802	AUC(0-inf) is defined as area under the curve of JNJ-64281802 from time 0 to infinity time.	Up to Day 62
Primary	Area Under the Curve From Time Zero to tau (AUC[0-tau]) of JNJ-64281802	AUC(0-tau) is defined as area under the curve from time 0 to tau hours post dose of JNJ-64281802.	Up to Day 62
Primary	Total Apparent Oral Clearance (CL/F) of JNJ-64281802	CL/F is defined as total apparent oral clearance of JNJ-64281802.	Up to Day 62
Secondary	Number of Participants with Adverse Events (AEs)	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.	Up to 62 days
Secondary	Number of Participants with Abnormalities in 12-lead Electrocardiograms (ECGs)	Number of participants with abnormalities in 12-lead ECGs will be reported.	Up to 62 days
Secondary	Number of Participants with Abnormalities in Physical Examinations	Number of participants with abnormalities in physical examinations (including skin examination, height and body weight) will be reported.	Up to 62 days
Secondary	Number of Participants with Abnormalities in Vital Sign Measurements	Number of participants with abnormalities in vital sign measurements (including temperature, temporal artery measurements, pulse/heart rate and blood pressure) will be reported.	Up to 62 days
Secondary	Number of Participants with Abnormalities in Clinical Laboratory Tests	Number of participants with abnormalities in clinical laboratory tests (including hematology, serum chemistry and urinalysis) will be reported.	Up to 62 days