Erectile Dysfunction, Pulmonary Arterial Hypertension
Conditions
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.
Interventions
DRUGTPN171H
10 mg TPN171H tablets，single dose
Sponsors
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Vigonvita Life Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed