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

NCT05185011 | Completed Phase 1

• 1 other identifier: TPN171H-09
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Adverse events

  From administration of study drug through 7 days after administration of study drug

Study Arms (3)

mild hepatic impairment

EXPERIMENTAL

Subjects with mild hepatic impairment

Drug: TPN171H

moderate hepatic impairment

EXPERIMENTAL

Subjects with mild moderate impairment

Drug: TPN171H

healthy volunteers

EXPERIMENTAL

Subjects with normal hepatic function

Drug: TPN171H

Interventions

TPN171H DRUG

10 mg TPN171H tablets，single dose

healthy volunteers; mild hepatic impairment; moderate hepatic impairment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hepatic Insufficiency Participants：
• Signing the informed consent forms；
• Take proper contraceptive during the study and within 6 months after the study completed;
• years to 65 years (inclusive)；
• Male≥50kg，femal≥45kg, Body mass index should be between 18 and 30 kg/m2 (inclusive)；
• No medication was used before screening，or stable medication for 4 weeks. Liver cirrhosis；
• Child-Pugh class A or Child-Pugh class B, liver function impairment caused by previous primary liver disease (drug-induced liver injury was excluded)；
• The clinical diagnosis was liver cirrhosis.
• Normal liver function Participants：
• Signing the informed consent forms；
• Take proper contraceptive during the study and within 6 months after the study completed;
• years to 65 years (inclusive)；
• Male≥50kg，femal≥45kg, Body mass index should be between 18 and 30 kg/m2 (inclusive)；
• No medication was used before screening；
• Clinical laboratory tests during the screening period were normal，or the abnormality has no clinical significance.

You may not qualify if:

• Allergic constitution；
• Patients who have a history of NAION, or with a known genetically degenerative retinopathy, including retinitis pigmentosa；
• Patients with alcohol addiction or persistent abuse of drugs of dependence;
• Smoking more than 5 cigarettes per day within 3 months prior to screening；
• 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 screening；
• Within 28 days before screening, inhibitors or inducers of CYP3A4 were used；
• have a scheduled surgical plan during the study period;
• Patients with clinically significant ECG abnormalities；
• Creatinine clearance \<60ml/min;
• A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial；
• Screening positive for viral hepatitis (including hepatitis B and C), HIV or syphilis (normal liver function only) ；
• Urine drug screening positive；

Sponsors & Collaborators

• Vigonvita Life Sciences: lead
• Shanghai Institute of Materia Medica, Chinese Academy of Sciences: collaborator

Study Sites (1)

The First Affiliated Hospital of Jilin University

Changchun, China

Location

MeSH Terms

Conditions

Erectile Dysfunction; Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yan Hua Ding, MD

  The First Affiliated Hospital of Jilin University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: December 16, 2021
• Primary Completion: February 6, 2022
• Study Completion: February 6, 2022
• Last Updated: March 23, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)