Pulmonary Arterial HypertensionPhase 1NCT05208814
A Study to Evaluate the Pharmacokinetics and Safety of TPN171H Tablets in Patients with Renal Insufficiency and Healthy Subjects
A Phase 1 study testing TPN171H single dose in people with Pulmonary Arterial Hypertension and Erectile Dysfunction, run by Vigonvita Life Sciences at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension, Erectile Dysfunction
- What is being tested?
- TPN171H single dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesChina
- Study dates
- 31 Mar 2022to 25 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Common exclusion criteria of each group:
- 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;
Show all 25Show fewer
- 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;
- 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;
- 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;
- 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.).
- Subjects who have significant laboratory abnormalities related to renal insufficiency and its complications, which are clinically significant according to the judgment of the researcher;
- Subjects with diabetic nephropathy have a HbAlc > 8.5% and fasting blood glucose > 11.1mmol/L at least 4 weeks before treatment.
- The researcher believes that the subject's condition (such as blood pressure) is not suitable for the selection of this researcher;
- 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.
- 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.);
- Subjects who have renal insufficiency with renal anemia, Hb < 80 g / L;
Trial locations and contacts
2 sites in 1 country.
China2 sites
West China Hospital
Chengdu, Sichuan, 610041
Chengdu Xinhua Hospital
Chengdu, Sichuan, 610055
About this study
Official 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
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
Read the detailed description
The study design of two centers, parallel, open and single dose administration is adopted. The experiment is carried out in two stages, whether or not to start the second stage is according to the test results of the first stage.
The first stage: there are two groups: severe renal insufficiency group and healthy subjects group. 8 subjects in each group (both male and female), a total of 16 cases.
The second stage: part A or part B. Part A: there are two groups: non dialysis end-stage renal disease (ESRD) group, with 8 subjects (both men and women), in the group with healthy subjects , there are 0-8 subjects.
Part B: there are three groups: mild renal insufficiency, moderate renal insufficiency and healthy subjects. There are 8 subjects (both male and female) in both mild renal insufficiency group and moderate renal insufficiency group, and 0-8 subjects (both male and female) in the healthy subjects group.
The initiation criteria of second stage study are: if auc0-t of subjects with severe renal insufficiency in the first stage is less than twice that of subjects with healthy subjects, And expected in the end of nephropathy If there is no significant increase in safety risk among (non dialysis) subjects, it is decided to start the second stage part A study instead of the second stage part B study according to the results of the first stage; if the auc0-t of subjects with severe renal insufficiency in the first stage is more than twice that of subjects with healthy subjects, it is decided whether to start the second stage part B study instead of the second stage part A study according to the results of the first stage.
- Being tested
- TPN171H single dose
- Keywords
- TPN171H, renal insufficiency, Pharmacokinetics
- Medical subject headings
- Pulmonary Arterial Hypertension, Erectile Dysfunction, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPN171H single doseDrug
10 mg TPN171H taken once
| Study group | Role | What they receive |
|---|---|---|
| Renal Insuffiency | Experimental | Subjects with various degrees of renal insuffiency Receives: Drug: TPN171H single dose |
| healthy subjects | Experimental | healthy subjects Receives: Drug: TPN171H single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 72 hours or 120 hours after dosing
Adverse events
Number of Participants With treatment-related Adverse Events and Serious Adverse Events.
Measured: From administration of study drug through 8 days after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start31 Mar 2022
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Vigonvita Life SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Institute of Materia Medica, Chinese Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- Jia Miao, Principal investigator, West China HospitalPing Fu, Principal investigator, West China HospitalXiaolan Yong, Principal investigator, Chengdu Xinhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208814
- Sponsor's protocol ID
- TPN171H-10
- Status last verified
- Feb 2023
- First submitted
- 29 Dec 2021
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fu P, Song Y, Hu C, Yong X, Yu Y, Chen Y, Wang Y, Zhu X, Wang Z, Wang Y, Juan J, Chen Y, Miao J. A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Adults with Renal Impairment. Clin Pharmacol Drug Dev. 2025 Jun;14(6):479-486. doi: 10.1002/cpdd.1536. Epub 2025 Apr 21.
PubMed 40255110
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05208814
- Acronym / sponsor ID
- TPN171H-10
- Keywords
- TPN171H, renal insufficiency, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Institute of Materia Medica, Chinese Academy of Sciences
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The study design of two centers, parallel, open and single dose administration is adopted. The experiment is carried out in two stages, whether or not to start the second stage is according to the test results of the first stage.
The first stage: there are two groups: severe renal insufficiency group and healthy subjects group. 8 subjects in each group (both male and female), a total of 16 cases.
The second stage: part A or part B. Part A: there are two groups: non dialysis end-stage renal disease (ESRD) group, with 8 subjects (both men and women), in the group with healthy subjects , there are 0-8 subjects.
Part B: there are three groups: mild renal insufficiency, moderate renal insufficiency and healthy subjects. There are 8 subjects (both male and female) in both mild renal insufficiency group and moderate renal insufficiency group, and 0-8 subjects (both male and female) in the healthy subjects group.
The initiation criteria of second stage study are: if auc0-t of subjects with severe renal insufficiency in the first stage is less than twice that of subjects with healthy subjects, And expected in the end of nephropathy If there is no significant increase in safety risk among (non dialysis) subjects, it is decided to start the second stage part A study instead of the second stage part B study according to the results of the first stage; if the auc0-t of subjects with severe renal insufficiency in the first stage is more than twice that of subjects with healthy subjects, it is decided whether to start the second stage part B study instead of the second stage part A study according to the results of the first stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Insuffiency | Experimental | Drug: TPN171H single doseSubjects with various degrees of renal insuffiency |
| healthy subjects | Experimental | Drug: TPN171H single dosehealthy subjects |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (25 listed)
- Common exclusion criteria of each group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPN171H single dose10 mg TPN171H taken once | Drug | Renal Insuffiency, healthy subjects |
Primary outcome
Area under the curve (AUC)
Time frame: 72 hours or 120 hours after dosing
Area under the curve (AUC) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.
Time to maximum plasma concentration (Tmax)
Time frame: 72 hours or 120 hours after dosing
Time to maximum plasma concentration (Tmax) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.
Maximum plasma concentration (Cmax)
Time frame: 72 hours or 120 hours after dosing
Maximum plasma concentration (Cmax) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.
Terminal half-life (t 1/2)
Time frame: 72 hours or 120 hours
Terminal half-life (t 1/2) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.
Apparent distribution volume (Vd)
Time frame: 72 hours or 120 hours after dosing
Apparent distribution volume (Vd) for plasma and urine following a single dose of TPN171H in subjects with renal mpairment and healthy subjects.
Clearance rate (CL)
Time frame: 72 hours or 120 hours after dosing
Clearance rate (CL) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.
Oral bioavailability (F)
Time frame: 72 hours or 120 hours after dosing
Oral bioavailability (F) for plasma and urine following a single dose of TPN171H in subjects with renal insuffiency and healthy subjects.
Adverse events
Time frame: From administration of study drug through 8 days after administration of study drug
Number of Participants With treatment-related Adverse Events and Serious Adverse Events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Derived from this study: PubMed 40255110Fu P, Song Y, Hu C, Yong X, Yu Y, Chen Y, Wang Y, Zhu X, Wang Z, Wang Y, Juan J, Chen Y, Miao J. A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of TPN171 (a PDE5 Inhibitor) in Adults with Renal Impairment. Clin Pharmacol Drug Dev. 2025 Jun;14(6):479-486. doi: 10.1002/cpdd.1536. Epub 2025 Apr 21.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Arterial Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Miao principal investigator
West China Hospital
Ping Fu principal investigator
West China Hospital
Xiaolan Yong principal investigator
Chengdu Xinhua Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TPN171H single dose in people with Pulmonary Arterial Hypertension and Erectile Dysfunction, run by Vigonvita Life Sciences at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) (time frame: 72 hours or 120 hours after dosing). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05208814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.