Peking University Third Hospital
Beijing, 100089, China
NCT Number: NCT05703841
The purpose of the study is to assess what drug does to body when healthy Chinese participants receive single oral dose of JNJ-77242113.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Beijing, 100089, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-77242113 will be administered orally as an immediate-release (IR) file-coated tablet.
Other names: PN-21235, PN-235
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.
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.
Time frame: Predose up to Day 3
Cmax is defined as maximum observed plasma concentration 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.
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.
Time frame: Predose up to Day 3
CL/F is defined as apparent total systemic clearance after extravascular administration 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.
Time frame: Up to Day 35
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 ECGs will be reported.
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.
Time frame: Up to Day 35
Number of participants with abnormalities in clinical laboratory tests (including hematology, clinical chemistry, and urinalysis) will be reported.
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.
Janssen Research & Development, LLC
Industry
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of JNJ-77242113 Following Oral Administration in Healthy Chinese Adult Participants
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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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