NCT05374343Unknown1 期
A Phase I Study of the Pharmacokinetics/Pharmacodynamics and Safety of Rongliflozin in Chinese Subjects With Type 2 Diabetes With Normal Renal Function and Mild to Moderate Renal Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Plasma concentrations of rongliflozin
研究概览
简要总结
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients.
- •The subject is willing to take effective contraceptive measures without a pregnancy plan within 4 weeks after signing the informed consent form to taking the test drug.
- •When screening, 19.0 kg/m2 < or = body mass index (BMI) < or = 35.0 kg/m
- •No hypoglycemic drugs have been used in the 4 weeks before the baseline period, or stable doses of hypoglycemic drugs are being used.
- •No medications for other comorbidities or stable medication regimens within 4 weeks before the baseline period.
- •In the screening period, 6.5% < or = glycosylated hemoglobin < or =11.0%, and fasting blood glucose < or = 13.9 mmol/L.
- •Glomerular filtration rate (eGFR) > or = 90 mL/min/1.73m2 estimated according to the modified dietary trial for kidney disease (MDRD) formula (only applicable to patients with type 2 diabetes with normal renal function).
- •Accompanied by mild or moderate renal impairment, the eGFR calculated according to the MDRD formula meets the following criteria: mild renal impairment: 60~89 mL/min/1.73m2, moderate renal impairment: 30~59 mL/min/ 1.73m2 (only for patients with type 2 diabetes with impaired renal function).
- •Accompanied by mild or moderate renal impairment, accompanied by stable disease in the first 3 months of the baseline period (only applicable to patients with type 2 diabetes with renal impairment).
排除标准
- •Known allergy to sodium-glucose cotransporter 2 (SGLT2) inhibitor drugs or related excipients.
- •In the 3 months before screening, those who smoked more than 5 cigarettes per day on average or who could not give up smoking from signing informed consent to leaving the group.
- •Have a history of alcoholism.
- •Ingested any food or drink containing caffeine, xanthine, alcohol, grapefruit within 48 hours before taking the test drug.
- •Those who donate blood or lose a lot of blood (>400 mL) within 3 months before taking the test drug, or have a history of blood transfusion within 1 month before screening, or plan to donate blood within 1 month after the end of the trial.
- •Those who have taken the trial drug or such drugs within 1 month before taking the trial drug, or participated in the clinical trial of any drug or medical device within 3 months before screening.
- •Those who have a positive urine drug screen or have a history of drug abuse or drug use in the past 5 years.
- •The subject is breastfeeding or the serum pregnancy test result is positive.
- •Subjects had undergone surgery within 1 month before screening, or major surgery was planned during the study period.
- •Have severe mental illness or language barrier, unwilling or unable to fully understand and cooperate.
- •History or evidence of other diseases, such as history of repeated urinary tract infections, poorly controlled high blood pressure, type I diabetes, urinary incontinence, etc.
- •Abnormal laboratory tests, such as a) Alanine transaminase (ALT)/Aspartate aminotransferase (AST)>2.0×UNL and/or total bilirubin>1.5×UNL; b) hemoglobin <100 g/L; c) hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive , Syphilis antibody positive.
- •The researcher believes that the subject has any situation that may interfere with the interpretation of the pharmacokinetics, efficacy and safety data of this study.
- •Subjects considered by the researcher to be unsuitable to participate in this trial.
研究组 & 干预措施
Group A and C (normal kidney function)
Active Comparator
Each subject will receive a single dose of rongliflozin on Day 1
干预措施: pyroglutamate rongliflozin capsules (Drug)
Group B (mild renal impairment)
Experimental
Each subject will receive a single dose of rongliflozin on Day 1
干预措施: pyroglutamate rongliflozin capsules (Drug)
Group D (moderate renal impairment)
Experimental
Each subject will receive a single dose of rongliflozin on Day 1
干预措施: pyroglutamate rongliflozin capsules (Drug)
结局指标
主要结局
Plasma concentrations of rongliflozin
时间窗: 0 hour（pre-dose） to 96 hours after administration
Plasma concentrations of rongliflizin following the administration of a single dose of rongliflozin, the pharmacokinetic parameters for rongliflozin will be measured in varying degrees of kidney function.
次要结局
- Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function(Day -1 (Baseline) to Day 5)
研究者
研究点 (1)
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