Study of the Pharmacokinetics and Safety of TPN171H Tablets in Subjects With Mild ,Moderate Hepatic Insufficiency and Normal Liver Function

NCT ID: NCT05185011

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-16
• Study Completion Date: 2022-02-06

Brief Summary

The study aims to investigate and compare the effect of TPN171H on subjects with mild and moderate hepatic impairment compared to healthy subjects.

Conditions

Erectile Dysfunction; Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mild hepatic impairment

Subjects with mild hepatic impairment

Group Type: EXPERIMENTAL

TPN171H

Intervention Type: DRUG

10 mg TPN171H tablets，single dose

moderate hepatic impairment

Subjects with mild moderate impairment

Group Type: EXPERIMENTAL

TPN171H

Intervention Type: DRUG

10 mg TPN171H tablets，single dose

healthy volunteers

Subjects with normal hepatic function

Group Type: EXPERIMENTAL

TPN171H

Intervention Type: DRUG

10 mg TPN171H tablets，single dose

Interventions

TPN171H

10 mg TPN171H tablets，single dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Hepatic Insufficiency Participants：

1. Signing the informed consent forms；

2. Take proper contraceptive during the study and within 6 months after the study completed;

3. 18 years to 65 years (inclusive)；

4. Male≥50kg，femal≥45kg, Body mass index should be between 18 and 30 kg/m2 (inclusive)；

5. No medication was used before screening，or stable medication for 4 weeks. Liver cirrhosis；

6. Child-Pugh class A or Child-Pugh class B, liver function impairment caused by previous primary liver disease (drug-induced liver injury was excluded)；

7. The clinical diagnosis was liver cirrhosis.

Normal liver function Participants：

1. Signing the informed consent forms；

2. Take proper contraceptive during the study and within 6 months after the study completed;

3. 18 years to 65 years (inclusive)；

4. Male≥50kg，femal≥45kg, Body mass index should be between 18 and 30 kg/m2 (inclusive)；

5. No medication was used before screening；

6. Clinical laboratory tests during the screening period were normal，or the abnormality has no clinical significance.

Exclusion Criteria

1. Allergic constitution；

2. Patients who have a history of NAION, or with a known genetically degenerative retinopathy, including retinitis pigmentosa；

3. Patients with alcohol addiction or persistent abuse of drugs of dependence;

4. Smoking more than 5 cigarettes per day within 3 months prior to screening；

5. Drug abuse within 3 months prior to screening，or the long-term use of benzodiazepine medications；

6. Blood donation (or blood loss) ≥200mL, or receiving whole blood transfusions or erythrocyte suspension transfusions within 3 months prior to the screening；

7. Patients with severe or clinically significant infections, traumas, and major trauma surgery within 4 weeks before screening;

8. Participated in any other intervention clinical trial within 1 months before screening；

9. Within 28 days before screening, inhibitors or inducers of CYP3A4 were used；

10. have a scheduled surgical plan during the study period;

11. Patients with clinically significant ECG abnormalities；

12. Creatinine clearance <60ml/min;

13. A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial；

14. Screening positive for viral hepatitis (including hepatitis B and C), HIV or syphilis (normal liver function only) ；

15. Urine drug screening positive；

16. Any factors that the investigator considers inappropriate for participation in the study；

17. History of liver transplant;

18. History of any serious diseases, other than primary liver diseases, or history of disorders and/or clinically significant abnormal laboratory findings that, as judged by the investigator, may affect the results of the study, including but not limited to the history of diseases in the circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases;

19. Subjects with liver failure, acute liver injury ,or subjects with cirrhosis complicated with hepatocellular carcinoma or symptomatic hepatic encephalopathy, etc., are deemed as unsuitable for this study by the investigator；

20. ALT or AST >10*ULN，NE#<0.75*10^9/L,HGB<60g/L，AFP >100ng/ml；

21. Positive for HIV antibody screening; a rapid plasma reagin (RPR) test is required for a subject who tests positive for syphilis antibodies, and the subject should be excluded if the RPR result is also positive.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Institute of Materia Medica, Chinese Academy of Sciences

OTHER

Sponsor Role: collaborator

Vigonvita Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Hua Ding, MD

Role: STUDY_CHAIR

The First Affiliated Hospital of Jilin University

Locations

The First Affiliated Hospital of Jilin University

Changchun, , China

Countries

China

Other Identifiers

TPN171H-09

Identifier Type: -

Identifier Source: org_study_id