A Concentration-QT Interval Correction (C-QTc) study of MY008211A Tablets in Healthy Subjects
Volunteers must be fully informed of this study and the content, process of the study and possible adverse events related to experimental drug will be fully understood, and voluntarily signed a written Informed Consent Form (ICF);
18≤ age ≤ 45 years old, male or female Chinese adult volunteers;
Body weight: ≥50 kg for male, ≥45 kg for female; body mass index (BMI): 19.0-26.0 kg/m2 (inclusive) at screening;
Volunteers should be able to communicate well with the investigator, understand and comply with the requirements of the study.
The investigator judges that there are other disease or medical conditions that are clinical significant or may prevent the volunteer from following the study protocol and completing the study, abnormal including but not limited to central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, immune system, mental system, endocrine and metabolic system;
Volunteers with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, enteritis, active gastrointestinal bleeding, or gastrointestinal surgery within the past three years and judged by the investigator to have clinical significance at present;
Volunteers with torsades de pointes (TDP) or other risk factors for malignant arrhythmias, or short QT syndrome, long QT syndrome, sudden unexplained death or drowning in youth (≤ 40 years old), or a family history of a first-degree relative (i.e., biological parent, sibling, or child) of sudden infant death syndrome, or other heart disease that the investigators determined was not suitable for inclusion;
Volunteers with hyperkalemia, hypokalemia, hypermagnesia, hypomagnesemia, hypercalcemia or hypocalcemia and judged by the investigator to have clinical significance;
Parallel
MY008211A tablets
DrugSubjects of Group A receive MY008211A tablets on Day 1 of both Sequence, wash-out period is 6 Days at least.
Placebo
DrugSubjects of Group A receive placebo tablets on Day 1 of both Sequence, wash-out period is 6 Days at least.
ΔΔQTcF (Using Fridericia Formula as the Primary Method for QT Interval Correction)
Placebo-corrected, baseline-adjusted QTc interval of prodrug and active metabolite (if necessary)
Cmax (Maximum plasma concentration)
Cmax of prodrug and active metabolite (if necessary)
Tmax (Time to maximum plasma concentration)
Tmax of prodrug and active metabolite (if necessary)
t1/2 (Terminal elimination half-life time)
t1/2 of prodrug and active metabolite (if necessary)
AUC0-t (Area under the plasma concentration-time curve from time 0 to the collection time t with the last measurable plasma concentration)
AUC0-t of prodrug and active metabolite (if necessary)
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This trial is not recruiting at the moment. You can still explore other options:
