PKUcare Luzhong Hospital
Zibo, Shangdong, 255400, China
Location status: Recruiting
NCT Number: NCT07594847
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Phase 1
Zibo, Shangdong, 255400, China
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HDM1002 tablet, oral, 200 mg single dose
HDM1002 tablet, oral, 400 mg single dose
Placebo tablet, oral, single dose
Moxifloxacin tablet, oral, 400 mg single dose
Time frame: From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose
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
QTc, PR, and QRS expressed as msec, HR expressed as beats per minute
Time frame: 25 days
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Industry
A Phase I, Single-center, Randomized, Double-blind, Placebo- and Positive-controlled, Four-period, Crossover Clinical Study to Evaluate the Effect of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects
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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