A Phase 1 interventional study of JNJ-77242113 in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
The purpose of the study is to assess what drug does to body when healthy Chinese participants receive single oral dose of JNJ-77242113.
Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a single oral dose of JNJ-77242113 Dose 1 on Day 1.
Drug: JNJ-77242113
Participants will receive a single oral dose of JNJ-77242113 Dose 2 on Day 1.
Drug: JNJ-77242113
Participants will receive a single oral dose of JNJ-77242113 Dose 3 on Day 1.
Drug: JNJ-77242113
JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.
Also known as: PN-21235, PN-235
Area Under the Plasma Concentration versus Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-77242113
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.
Time frame: Predose up to Day 3
Area Under the Plasma Concentration versus Time Curve From Time Zero to Infinite Time (AUC[0-infinite]) of JNJ-77242113
AUC(0-infinite) is defined as area under the plasma concentration versus time curve from time zero to infinite time of JNJ-77242113.
Time frame: Predose up to Day 3
Maximum Observed Plasma Concentration (Cmax) of JNJ-77242113
Cmax is defined as maximum observed plasma concentration of JNJ-77242113.
Time frame: Predose up to Day 3
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-77242113
Tmax is defined as time to reach the maximum observed plasma concentration of JNJ-77242113.
Time frame: Predose up to Day 3
Apparent Elimination Half-life (T1/2) of JNJ-77242113
T1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of JNJ-77242113.
Time frame: Predose up to Day 3
Apparent Total Systemic Clearance (CL/F) of JNJ-77242113
CL/F is defined as apparent total systemic clearance after extravascular administration of JNJ-77242113.
Time frame: Predose up to Day 3
Apparent Volume of Distribution (Vz/F) of JNJ-77242113
Vz/F is defined as apparent volume based on terminal phase after extravascular administration of distribution of JNJ-77242113.
Time frame: Predose up to Day 3
Number of Participants with Abnormalities in Physical Examinations
Number of participants with abnormalities in physical examinations will be reported.
Time frame: Up to Day 35
Number of Participants with Abnormalities in 12-Lead Electrocardiogram (ECG)
Number of participants with abnormalities in 12-lead ECGs will be reported.
Time frame: Up to Day 35
Number of Participants with Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported.
Time frame: Up to Day 35
Number of Participants with Abnormalities in Clinical Laboratory Tests
Number of participants with abnormalities in clinical laboratory tests (including hematology, clinical chemistry, and urinalysis) will be reported.
Time frame: Up to Day 35
Number of Participants with Adverse Events (AEs)
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.
Time frame: Up to Day 35
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Janssen Research & Development, LLC