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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 January 2025
• Main ID: NCT05208814
• Date of registration: 29/12/2021
• Prospective Registration: Yes
• Primary sponsor: Vigonvita Life Sciences
• Public title: A Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients with Renal Insufficiency and Healthy Subjects
• Scientific title: A Parallel, Open, Single-dose Administration Phase I Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients with Renal Insufficiency and Healthy Subjects
• Date of first enrolment: March 31, 2022
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT05208814
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: Jia Miao
• Affiliation: West China Hospital

• Name: Xiaolan Yong
• Affiliation: Chengdu Xinhua Hospital

• Name: Ping Fu
• Affiliation: West China Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 18-70 years old, both male and female;

2. Weight: male = 50 kg, female = 45 kg, 18 kg/m2 = BMI = 30 kg/m2 ;

3. 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;

4. 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.

Exclusion Criteria:

- Common exclusion criteria of each group:

1. Dysphagia;

2. Arrhythmia with clinical significance, or QTCF > 450ms (male) and QTCF > 470ms
(female);

3. 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.

4. Subjects with history of drug allergy, allergic constitution and family history
of allergy;

5. 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;

6. 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.

7. 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;

8. Subjects who participated in the drug clinical trial within 3 months before the
trial;

9. 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;

10. 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;

11. Subjects who cannot tolerate venipuncture, or have a history of needle fainting
and blood fainting;

12. 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;

13. The researchers believe that subjects with any factors that are not suitable to
participate in this trial.

- Exclusion criteria for healthy subjects:

1. 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;

2. Subjects whose systolic blood pressure < 85mmHg or > 140mmHg, diastolic blood
pressure < 55mmHg or > 90mmHg;

3. Subjects who have previous or existing diseases of liver, kidney, endocrine,
digestive system, urinary system, cardiovascular system, nervous system,
respiratory system (such as asthma, chronic obstructive bronchitis, etc.),
blood and lymphatic system, nervous system (such as multiple headache), mental
diseases and other diseases with clinical significance judged by the research
doctor;

4. Subjects who have used any drugs (including prescription drugs,
over-the-counter drugs, vitamin supplements or Chinese herbal medicine) and
health products within 2 weeks before screening;

- Exclusion criteria for subjects with renal insufficiency:

1. 1 years before the start of the trial, subjects who have serious diseases such
as cardiovascular, neuropsychiatric, digestive, respiratory, endocrine and
other systems besides renal insufficiency basic diseases and their
complications (such as diabetic nephropathy, renal anemia, renal hypertension,
etc.).

2. Subjects who have significant laboratory abnormalities related to renal
insufficiency and its complications, which are clinically significant according
to the judgment of the researcher;

3. Subjects with diabetic nephropathy have a HbAlc > 8.5% and fasting blood
glucose > 11.1mmol/L at least 4 weeks before treatment.

4. The researcher believes that the subject's condition (such as blood pressure)
is not suitable for the selection of this researcher;

5. Subjects with renal insufficiency have no evidence of a history of chronic
diseases lasting more than 1 months, including but not limited to chronic
glomerulonephritis, benign glomerular arteriosclerosis, obstructive nephropathy
or diabetes, and the results of the study indicate that the GFR of subjects may
change significantly during the study period.

6. During the period from 1 month before taking the test drug to the end of the
study, the investigator judge that there is no stable scheme for the treatment
of renal function insufficiency and its complications (medication type, dose or
medication frequency, etc.);

7. Subjects who have renal insufficiency with renal anemia, Hb < 80 g / L;


Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Erectile Dysfunction

Pulmonary Arterial Hypertension

Intervention(s)

Drug: TPN171H single dose

Primary Outcome(s)

Area under the curve (AUC) [Time Frame: 72 hours or 120 hours after dosing]

Adverse events [Time Frame: From administration of study drug through 8 days after administration of study drug]

Clearance rate (CL) [Time Frame: 72 hours or 120 hours after dosing]

Apparent distribution volume (Vd) [Time Frame: 72 hours or 120 hours after dosing]

Maximum plasma concentration (Cmax) [Time Frame: 72 hours or 120 hours after dosing]

Oral bioavailability (F) [Time Frame: 72 hours or 120 hours after dosing]

Terminal half-life (t 1/2) [Time Frame: 72 hours or 120 hours]

Time to maximum plasma concentration (Tmax) [Time Frame: 72 hours or 120 hours after dosing]

Secondary ID(s)

TPN171H-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shanghai Institute of Materia Medica, Chinese Academy of Sciences