A Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients with Renal Insufficiency and Healthy Subjects

NCT05208814 | Completed Phase 1

• 1 other identifier: TPN171H-10
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the effect of renal insufficiency on the pharmacokinetics of TPN171H tablets after single dose oral administration, so as to provide basis for formulating clinical medication plan for patients with renal insufficiency; To evaluate the safety of TPN171H tablets in patients with renal insufficiency and healthy subjects

Conditions

Pulmonary Arterial Hypertension; Erectile Dysfunction

Keywords

TPN171H; renal insufficiency; Pharmacokinetics

Outcome Measures

Primary Outcomes (8)

• Area under the curve (AUC)

  Area under the curve (AUC) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.

  72 hours or 120 hours after dosing

• Time to maximum plasma concentration (Tmax)

  Time to maximum plasma concentration (Tmax) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.

  72 hours or 120 hours after dosing

• Maximum plasma concentration (Cmax)

  Maximum plasma concentration (Cmax) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.

  72 hours or 120 hours after dosing

• Terminal half-life (t 1/2)

  Terminal half-life (t 1/2) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.

  72 hours or 120 hours

• Apparent distribution volume (Vd)

  Apparent distribution volume (Vd) for plasma and urine following a single dose of TPN171H in subjects with renal mpairment and healthy subjects.

  72 hours or 120 hours after dosing

• Clearance rate (CL)

  Clearance rate (CL) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.

  72 hours or 120 hours after dosing

• Oral bioavailability (F)

  Oral bioavailability (F) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.

  72 hours or 120 hours after dosing

• Adverse events

  Number of Participants With treatment-related Adverse Events and Serious Adverse Events.

  From administration of study drug through 8 days after administration of study drug

Study Arms (2)

Renal Insuffiency

EXPERIMENTAL

Subjects with various degrees of renal insuffiency

Drug: TPN171H single dose

healthy subjects

EXPERIMENTAL

healthy subjects

Drug: TPN171H single dose

Interventions

TPN171H single dose DRUG

10 mg TPN171H taken once

Renal Insuffiency; healthy subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years old, both male and female;
• Weight: male ≥ 50 kg, female ≥ 45 kg, 18 kg/m2 ≤ BMI ≤ 30 kg/m2 ;
• Healthy subjects meet: GFR ≥ 90ml / min and \< 130ml / min; the GFR of the subjects in the corresponding group meet the criteria of MDRD in the stage of renal function. Mild renal insufficiency (CKD 2 stage) : GFR : 60-89 mL/min; moderate renal insufficiency (CKD 3 stage) : GFR : 30-59mL/min; Severe renal insufficiency (CKD 4): GFR: 15-29 mL/min; renal failure (CKD 5) : GFR\<15 mL/min；
• Be able to understand the procedures and methods of this study, be willing to strictly abide by the clinical trial scheme, complete this trial, and voluntarily sign the informed consent.

You may not qualify if:

• Dysphagia;
• Arrhythmia with clinical significance, or QTCF \> 450ms (male) and QTCF \> 470ms (female);
• Subjects with acute hepatitis, chronic liver disease, positive treponema pallidum antibody, positive HBV surface antigen, positive HCV antibody and positive HIV antibody; Or either ALT or AST is greater than 2 times the upper limit of the normal value, and the total bilirubin is greater than 1.5 times the upper limit of the normal value.
• Subjects with history of drug allergy, allergic constitution and family history of allergy;
• Subjects who have used drugs that affect the function of liver metabolic enzymes within 30 days before the start of the test, or those who need to use other drugs that may affect the absorption, distribution, metabolism and excretion of the tested drugs during the test;
• Subjects who drink too much (more than 8 cups a day, 1 cup = 250mL) of tea, coffee or caffeinated beverages within 6 months before screening; or those who consumed any food or beverage rich in caffeine and / or xanthine within 48 hours before the first administration of the study to the end of the test.
• Subjects who have a history of alcohol, tobacco and drug abuse; subjects whose alcohol breath test is positive, and urine drugs (morphine, tetrahydrocannabinol acid, methamphetamine, dimethylbisoxyamphetamine, ketamine) screening results are positive;
• Subjects who participated in the drug clinical trial within 3 months before the trial;
• Subjects who participate in blood donation within 3 months from the beginning of the test and the blood donation volume is ≥ 400mL or receive blood transfusion;
• Subjects who have undergone surgery within 4 weeks before screening, or plan to perform surgery during the study or within 2 weeks after the end of the study;
• Subjects who cannot tolerate venipuncture, or have a history of needle fainting and blood fainting;
• Women of childbearing age with positive pregnancy test, or pregnant and lactating women and subjects who are unwilling or unable to take physical contraceptives during the test;
• The researchers believe that subjects with any factors that are not suitable to participate in this trial.
• Subjects whose physical examination, vital signs, blood routine, blood biochemistry, urine routine, coagulation function, full chest positive film and 12 lead ECG, at least one of which is judged by the researcher to be abnormal and of clinical significance;
• Subjects whose systolic blood pressure \< 85mmHg or \> 140mmHg, diastolic blood pressure \< 55mmHg or \> 90mmHg;

Sponsors & Collaborators

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

Study Sites (2)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Chengdu Xinhua Hospital

Chengdu, Sichuan, 610055, China

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Erectile Dysfunction; Renal Insufficiency

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Jia Miao

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Ping Fu

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Xiaolan Yong

  Chengdu Xinhua Hospital

  PRINCIPAL INVESTIGATOR

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 29, 2021
• First Posted: January 26, 2022
• Study Start: March 31, 2022
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: December 24, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)