A Study to Evaluate the Effect of JNJ-63623872 on Cardiac Repolarization Interval in Healthy Part… (NCT02658825) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Effect of JNJ-63623872 on Cardiac Repolarization Interval in Healthy Participants
Belgium66 participantsStarted 2016-01
Plain-language summary
The purpose of this study is to evaluate the effect of JNJ-63623872 on the QT/QTc interval at supratherapeutic exposure in healthy participants (Panel 2).
Who can participate
Age range18 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Each participant must sign an Informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
* Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
* A female participant must agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the (last dose of) study drug
* A male participant who is sexually active with a woman of childbearing potential must agree to use two effective methods of contraception during the study and for at least 90 days after receiving the (last dose of) study drug, and a male participant must also not donate sperm during the study and for at least 90 days after receiving the (last dose of) study drug
* Participants must be non-smokers for at least 3 months prior to Screening
* Participants must have a Body Mass Index (BMI) between 18.0 and 30.0 kilogram per meter\^2 (kg/m\^2) (inclusive) at Screening
Exclusion Criteria:
* Participant has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neuro…
What they're measuring
1
Change From Baseline in Corrected QT Interval (QTc) at Different Time Points
Timeframe: 45, 30 and 15 minutes predose and 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hours postdose on Day 1