Celerion
Lincoln, Nebraska, 68502, United States
NCT Number: NCT05541315
The purpose of this study is to assess the safety and tolerability of a single oral dose of JNJ-88260237 in healthy participants
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Notify Me25 year–55 year
All sexes
Interventional
Phase 1
Lincoln, Nebraska, 68502, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-88260237 will be administered orally.
Matching placebo will be administered orally.
Time frame: Up to Day 14
Number of participants with AEs will be reported.
Time frame: Up to Day 24
Number of participants with AEs will be reported.
Time frame: Up to Day 7
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 21
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 7
Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.
Time frame: Up to Day 21
Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported.
Time frame: Up to Day 7
Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.
Time frame: Up to Day 21
Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported.
Time frame: Up to Day 7
Number of participants with abnormalities in physical examinations will be reported.
Time frame: Up to Day 21
Number of participants with abnormalities in physical examinations will be reported.
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Cmax is defined as the maximum whole blood concentration of JNJ-88260237.
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Tmax is defined as the time to reach the maximum whole blood concentration of JNJ-88260237.
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
AUC (0-Last) is defined as the area under the whole blood concentration versus time curve from time zero to time of the last measurable concentration of JNJ-88260237.
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
AUC (0-infinity) is defined as the area under the whole blood concentration versus time curve from time zero to infinite time of JNJ-88260237.
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
T1/2 is defined as the terminal half-life of JNJ-88260237.
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
CL/F is defined as apparent oral whole blood clearance of JNJ-88260237.
Time frame: Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21
Vz/F is defined as the apparent volume of distribution of JNJ-88260237.
Janssen Research & Development, LLC
Industry
A Double-blind, Randomized, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-88260237 in Healthy Participants
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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