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Completed

NCT Number: NCT05703841

A Study of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants

The purpose of the study is to assess what drug does to body when healthy Chinese participants receive single oral dose of JNJ-77242113.

Completed

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital

Beijing, 100089, China

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, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are any abnormalities, they must be consistent with the underlying illness in the study population or considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
  • Body mass index (BMI; weight kilograms [kg] per height [meter^2]) between 18.0 and 27.9 kilograms per meter^2 (kg/m2) (inclusive), and body weight not less than 50.0 kg at screening
  • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and on Day -1
  • Blood pressure (after the participant is supine for 5 minutes) between 90 (inclusive) and 140 millimeters of mercury (mmHg) (exclusive) systolic, and no higher than 90 mm Hg diastolic
  • Must be a nonsmoker or habitually smokes no more than 5 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before study drug administration

Exclusion criteria

  • History of surgical resection of the stomach, small or large intestine (excluding appendectomy, cholecystectomy, or resection of benign polyps)
  • History of use of medications such as nonsteroidal anti-inflammatory drugs (NSAIDS) or aspirin within 28 days prior to screening or planned use during the study
  • Clinically significant infection within 30 days prior to screening or any serious infection within 6 months prior to screening requiring intravenous antimicrobial therapy
  • Known allergies, hypersensitivity, or intolerance to JNJ-77242113 or its excipients
  • History of severe allergic or anaphylactic reactions

Treatment and study plan

JNJ-77242113

Drug

JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.

Other names: PN-21235, PN-235

Primary outcomes

  1. Area Under the Plasma Concentration versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-77242113

    Time frame: Predose up to Day 3

    AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to time of the last measurable concentration of JNJ-77242113.

  2. Area Under the Plasma Concentration versus Time Curve From Time Zero to Infinite Time (AUC[0-infinite]) of JNJ-77242113

    Time frame: Predose up to Day 3

    AUC(0-infinite) is defined as area under the plasma concentration versus time curve from time zero to infinite time of JNJ-77242113.

  3. Maximum Observed Plasma Concentration (Cmax) of JNJ-77242113

    Time frame: Predose up to Day 3

    Cmax is defined as maximum observed plasma concentration of JNJ-77242113.

  4. Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-77242113

    Time frame: Predose up to Day 3

    Tmax is defined as time to reach the maximum observed plasma concentration of JNJ-77242113.

  5. Apparent Elimination Half-life (T1/2) of JNJ-77242113

    Time frame: Predose up to Day 3

    T1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of JNJ-77242113.

  6. Apparent Total Systemic Clearance (CL/F) of JNJ-77242113

    Time frame: Predose up to Day 3

    CL/F is defined as apparent total systemic clearance after extravascular administration of JNJ-77242113.

  7. Apparent Volume of Distribution (Vz/F) of JNJ-77242113

    Time frame: Predose up to Day 3

    Vz/F is defined as apparent volume based on terminal phase after extravascular administration of distribution of JNJ-77242113.

Secondary outcomes

  1. Number of Participants with Abnormalities in Physical Examinations

    Time frame: Up to Day 35

    Number of participants with abnormalities in physical examinations will be reported.

  2. Number of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG)

    Time frame: Up to Day 35

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

  3. Number of Participants with Abnormalities in Vital Signs

    Time frame: Up to Day 35

    Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.

  4. Number of Participants with Abnormalities in Clinical Laboratory Tests

    Time frame: Up to Day 35

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

  5. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Day 35

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 30, 2023
Registry last updated
Jun 5, 2023

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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