The aim of this trial is to evaluate the effect of a single oral dose of HDM1002 tablets on the QT/QTc interval in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
HDM1002 tablet, oral, 200 mg single dose
HDM1002 tablet, oral, 400 mg single dose
Placebo tablet, oral, single dose
PKUcare Luzhong Hospital
Zibo, Shangdong, China
RECRUITINGCorrelation between HDM1002 Plasma Concentration and ΔΔQTc
HDM1002 plasma concentration in ng/mL measured by validated LC-MS/MS; ΔΔQTc in msec derived from Fridericia-corrected QT interval with baseline and placebo correction, using 12-lead ECG read centrally in a blinded manner.
Time frame: From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose
Categorical outliers for QTc, HR, PR, and QRS
QTc, PR, and QRS expressed as msec, HR expressed as beats per minute
Time frame: From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 25 days
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