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| Name | Class |
|---|---|
| Shanghai Institute of Materia Medica, Chinese Academy of Sciences | OTHER |
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The study aims to investigate and compare the effect of TPN171H on subjects with mild and moderate hepatic impairment compared to healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mild hepatic impairment | Experimental | Subjects with mild hepatic impairment |
|
| moderate hepatic impairment | Experimental | Subjects with mild moderate impairment |
|
| healthy volunteers | Experimental | Subjects with normal hepatic function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPN171H | Drug | 10 mg TPN171H tablets,single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Maximum Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients | 72 hours after dosing |
| Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity(AUC0-∞) | 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 | 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) | 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 | 72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of Participants With Adverse Events and Serious Adverse Events | From administration of study drug through 7 days after administration of study drug |
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Inclusion Criteria:
Hepatic Insufficiency Participants:
Normal liver function Participants:
Exclusion Criteria:
Allergic constitutionï¼›
Patients who have a history of NAION, or with a known genetically degenerative retinopathy, including retinitis pigmentosaï¼›
Patients with alcohol addiction or persistent abuse of drugs of dependence;
Smoking more than 5 cigarettes per day within 3 months prior to screeningï¼›
Drug abuse within 3 months prior to screening,or the long-term use of benzodiazepine medications;
Blood donation (or blood loss) ≥200mL, or receiving whole blood transfusions or erythrocyte suspension transfusions within 3 months prior to the screening;
Patients with severe or clinically significant infections, traumas, and major trauma surgery within 4 weeks before screening;
Participated in any other intervention clinical trial within 1 months before screeningï¼›
Within 28 days before screening, inhibitors or inducers of CYP3A4 were usedï¼›
have a scheduled surgical plan during the study period;
Patients with clinically significant ECG abnormalitiesï¼›
Creatinine clearance <60ml/min;
A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trialï¼›
Screening positive for viral hepatitis (including hepatitis B and C), HIV or syphilis (normal liver function only) ï¼›
Urine drug screening positiveï¼›
Any factors that the investigator considers inappropriate for participation in the studyï¼›
Additional exclusion criteria for subjects with hepatic insufficiency (those who meet any of the followings are ineligible):
History of liver transplant;
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;
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 investigatorï¼›
ALT or AST >10*ULN,NE#<0.75*10^9/L,HGB<60g/L,AFP >100ng/ml;
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.
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| Name | Affiliation | Role |
|---|---|---|
| Yan Hua Ding, MD | The First Affiliated Hospital of Jilin University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Jilin University | Changchun | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40277393 | Derived | Zhou J, Zhang H, Ding Y, Wang Z, Wang Y, Juan J, Jiang Z, Chen H. Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Patients With Mild or Moderate Hepatic Impairment Versus Participants With Normal Hepatic Function: A Phase 1 Study. Clin Pharmacol Drug Dev. 2025 Jun;14(6):472-478. doi: 10.1002/cpdd.1535. Epub 2025 Apr 25. |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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