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

Phase 1

Completed

• Conditions: Pulmonary Arterial Hypertension; Erectile Dysfunction
• Interventions: Drug: TPN171H

• Registration Number: NCT05185011
• Lead Sponsor: Vigonvita Life Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-16
• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2021-12-22
• Study First Posted: 2022-01-11
• Primary Completion: 2022-02-06
• Study Completion: 2022-02-06
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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；

    Additional exclusion criteria for subjects with hepatic insufficiency (those who meet any of the followings are ineligible):

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mild hepatic impairment	TPN171H	Subjects with mild hepatic impairment
moderate hepatic impairment	TPN171H	Subjects with mild moderate impairment
healthy volunteers	TPN171H	Subjects with normal hepatic function

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity（AUC0-∞）	72 hours after dosing	Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity（AUC0-∞） will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients
Maximum Plasma Concentration (Cmax)	72 hours after dosing	Maximum Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients
Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration （AUC0-t）	72 hours after dosing	Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration （AUC0-t） will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients

Secondary Outcome Measures

Name	Time	Method
Adverse events	From administration of study drug through 7 days after administration of study drug	Number of Participants With Adverse Events and Serious Adverse Events

Trial Locations

Locations (1)

The First Affiliated Hospital of Jilin University; 🇨🇳 Changchun, China