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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM1002 200 mg | Experimental |
| |
| HDM1002 400 mg | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Moxifloxacin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM1002 200 mg | Drug | HDM1002 tablet, oral, 200 mg single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation 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. | From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Categorical outliers for QTc, HR, PR, and QRS | QTc, PR, and QRS expressed as msec, HR expressed as beats per minute | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PKUcare Luzhong Hospital | Recruiting | Zibo | Shangdong | 255400 | China |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| HDM1002 400 mg |
| Drug |
HDM1002 tablet, oral, 400 mg single dose |
|
| Placebo | Drug | Placebo tablet, oral, single dose |
|
| Moxifloxacin 400 mg | Drug | Moxifloxacin tablet, oral, 400 mg single dose |
|
| 25 days |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |