A Clinical Study to Access the Pharmacokinetics of HMS5552 in Renal Impaired Subjects and Healthy Volunteers

• Status: Completed
• Trial end date: 2019-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study is to access the pharmacokinetics and safety of HMS5552 in single dose in renal impaired subjects and matched healthy adult subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hua Medicine Limited

Criteria

Inclusion Criteria:

• For renal impaired subjects:

1. Male and female subjects between ages of 18 and 65 years, no less than 3 subjects in each gender.

2. Body weight≥50kg for male and ≥45kg for female； BMI: 18.5~30 kg/m2

3. eGFR: P1 < 15 mL/min/1.73 m2；P2: 15～29 mL/min/1.73 m2；P3: eGFR 30～59 mL/min/1.73 m2；P4: 60～89 mL/min/1.73 m2，and ACR≥ 3 mg/mmol；

4. Normal physical conditions, vital signs,12 lead ECG and laboratory recording, blood potassium 3.5~5.5mmol/L;

5. Left ventricular ejection fraction (LVEF) ≥50%

6. Willing to sign the informed consent form (ICF) and take reliable contraceptive measures within 6 months after taking the last dose of study drug;

7. Willing to adhere to the protocol requirement.

• For healthy volunteers:

1. Male and female subjects between ages of 18 and 65 years, no less than 3 subjects in each gender.

2. Body weight≥50kg for male and ≥45kg for female； BMI: 18.5~30 kg/m2

3. MDRD eGFR: ≥90 mL/min/1.73 m2；

4. Gender, age (±5 years) and BMI (±15%) matched with corresponding subject in P1 group

5. Normal physical conditions, vital signs,12 lead ECG and laboratory recording

6. Systolic pressure: 90～140 mmHg，diastolic pressure:50～90 mmHg；

7. Willing to sign the informed consent form (ICF) and take reliable contraceptive measures within 6 months after taking the last dose of study drug;

8. Willing to adhere to the protocol requirement.

Exclusion Criteria:

• Subjects with impaired renal function cannot be enrolled if they meet one of the following criteria:

1. Acute renal failure;

2. History of allergy;

3. In addition to renal impaired function, investigators adjudicate subjects have diseases that may affect drug absorption, distribution, metabolism or excretion;

4. Any other disease may receive treatment or surgery during the study

5. Abnormal of ECG performance or laboratory recording;

6. Family history of QT prolongation syndrome;

7. Have unstable cardiovascular disease, lung disease, gastrointestinal disease, liver disease, blood disease, mental disease, nervous system disease, immune deficiency disease or any malignant tumor;

8. History of cardiovascular and cerebrovascular disease;

9. Hear failure (NYHA) class III or IV;

10. Severe anemia, CHC<6.0g/dl at screening;

11. Severe infection, trauma, gastrointestinal operation or other surgery within 4 weeks before screening;

12. History of a) Type 1 diabetes, b) Acute complications of diabetes;

13. Serious hypoglycemia events within 3 months before screening;

14. More than 5 cigarettes per day within 3 months before screening;

15. Alcohol addicts;

16. History of drug abuse;

• Healthy subjects cannot be enrolled if they meet one of the following criteria:

1. History of allergy;

2. Investigators adjudicate subjects have diseases that may affect drug absorption, distribution, metabolism or excretion;

3. Any other disease may receive treatment or surgery during the study

4. Abnormal of ECG performance or laboratory recording;

5. Family history of QT prolongation syndrome;

6. Have unstable cardiovascular disease, lung disease, gastrointestinal disease, liver disease, blood disease, mental disease, nervous system disease, immune deficiency disease or any malignant tumor; history of cardiovascular and cerebrovascular disease within 6 months before screening; severe infection, trauma, gastrointestinal operation or other surgery within 4 weeks before screening;

7. Anemia caused by any reason;

8. History of hypoglycemia (<3.9mmol/L);

9. More than 5 cigarettes per day within 3 months before screening;

10. Alcohol addicts;

11. History of drug abuse;