Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-24 @ 10:03 PM
NCT ID:
NCT05032235
Eligibility Criteria:
Inclusion Criteria:
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Inclusion Criteria for subjects with impaired kidney function:
1. Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial;
2. Male or female subjects aged 18 to 70 (including 18 and 70);
3. Body mass index (BMI) ranges from 18 kg/m2 to 28 kg/m2 (including 18 and 28);
4. The glomerular filtration rate should meet the following criteria (GFR, mL/min):Subjects with mild renal impairment (CKD2): 60-89 mL/min (including 60-89);Subjects with moderate renal impairment (CKD3): 30-59 mL/min (including 30-59 ends);
5. Renal function should be stable, and the GFR results should be tested twice before administration (at least 3 days apart) within the same CKD stage.
Inclusion Criteria for subjects with normal kidney function:
1. Sign the informed consent before the trial and fully understand the content, process, and possible adverse reactions of the trial;
2. Male or female subjects aged 18 to 70 (including 18 and 70);
3. Body mass index (BMI) ranges from 18 kg/m2 to 28 kg/m2 (including 18 and 28);
4. Glomerular filtration rate (GFR) ≥90 mL/min.
Exclusion Criteria:
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Exclusion Criteria for subjects with impaired kidney function:
1. History of kidney transplant;
2. Need Renal dialysis during the study;
3. Urinary incontinence or anuria;
4. Clinically significant heart disease, including but not limited to: congestive heart failure, symptomatic coronary artery disease, myocardial infarction, QTcF≥470 ms (female) or QTcF≥450 ms (male) within 12 months before the start of treatment;
5. Received any investigational drug within 3 months before the study started;
6. Taking any drugs which can affect the metabolic enzyme CYP3A within 14 days before the study started;
7. Smokers and alcoholics, or those screened positive for alcohol;
8. History of drug use, or drug abuse screening positive.
Exclusion Criteria for subjects with normal kidney function:
1. History of kidney transplant;
2. Clinically significant heart disease, including but not limited to: congestive heart failure, symptomatic coronary artery disease, myocardial infarction, QTcF≥470 ms (female) or QTcF≥450 ms (male) within 12 months before the start of treatment;
3. Received any investigational drug within 3 months before the study started;
4. Taking any drugs which can affect the metabolic enzyme CYP3A within 14 days before the study started;
5. Smokers and alcoholics, or those screened positive for alcohol;
6. History of drug use, or drug abuse screening positive.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05032235
Study Brief:
Protocol Section:
NCT05032235