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Completed

NCT Number: NCT05201937

A Study of JNJ-64281802 in Healthy Adult Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

JNJ-64281802

Drug

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

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of JNJ-64281802

    Time frame: Up to Day 62

    Cmax is defined as maximum observed plasma concentration of JNJ-64281802.

  2. Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-64281802

    Time frame: Up to Day 62

    Tmax is defined the actual sampling time to reach the maximum observed plasma concentration of JNJ-64281802.

  3. Observed Plasma Concentration of JNJ-64281802 Just Prior to the Beginning of a Dosing Interval (Ctrough)

    Time frame: Up to Day 62

    Ctrough is defined as observed plasma concentration of JNJ-64281802 just prior to the beginning of a dosing interval.

  4. Apparent Terminal Elimination Half-life (t1/2) of JNJ-64281802

    Time frame: Up to Day 62

    t1/2 is defined as apparent terminal elimination half-life of JNJ-64281802.

  5. Area Under the Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of JNJ-64281802

    Time frame: 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.

  6. Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of JNJ-64281802

    Time frame: Up to Day 62

    AUC(0-inf) is defined as area under the curve of JNJ-64281802 from time 0 to infinity time.

  7. Area Under the Curve From Time Zero to tau (AUC[0-tau]) of JNJ-64281802

    Time frame: 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.

  8. Total Apparent Oral Clearance (CL/F) of JNJ-64281802

    Time frame: Up to Day 62

    CL/F is defined as total apparent oral clearance of JNJ-64281802.

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: 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.

  2. Number of Participants with Abnormalities in 12-lead Electrocardiograms (ECGs)

    Time frame: Up to 62 days

    Number of participants with abnormalities in 12-lead ECGs will be reported.

  3. Number of Participants with Abnormalities in Physical Examinations

    Time frame: Up to 62 days

    Number of participants with abnormalities in physical examinations (including skin examination, height and body weight) will be reported.

  4. Number of Participants with Abnormalities in Vital Sign Measurements

    Time frame: 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.

  5. Number of Participants with Abnormalities in Clinical Laboratory Tests

    Time frame: Up to 62 days

    Number of participants with abnormalities in clinical laboratory tests (including hematology, serum chemistry and urinalysis) will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 21, 2022
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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