Erectile DysfunctionPhase 1NCT05185011
Study of the Pharmacokinetics and Safety of TPN171H Tablets in Subjects With Mild ,Moderate Hepatic Insufficiency and Normal Liver Function
A Phase 1 study testing TPN171H in people with Erectile Dysfunction and Pulmonary Arterial Hypertension, run by Vigonvita Life Sciences at 1 site in China.
Trial summary
The study aims to investigate and compare the effect of TPN171H on subjects with mild and moderate hepatic impairment compared to healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Pulmonary Arterial Hypertension
- What is being tested?
- TPN171H
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2021to 6 Feb 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hepatic Insufficiency Participants：
- Signing the informed consent forms；
- Take proper contraceptive during the study and within 6 months after the study completed;
- 18 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；
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- 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;
- 18 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.
Who cannot join
- 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；
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- 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；
- Any factors that the investigator considers inappropriate for participation in the study；
- 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 investigator；
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Study of the Pharmacokinetics and Safety of TPN171H Tablets in Subjects With Mild Liver Insufficiency, Moderate Liver Insufficiency and Normal Liver Function
The study aims to investigate and compare the effect of TPN171H on subjects with mild and moderate hepatic impairment compared to healthy subjects.
- Being tested
- TPN171H
- Medical subject headings
- Erectile Dysfunction, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPN171HDrug
10 mg TPN171H tablets，single dose
| Study group | Role | What they receive |
|---|---|---|
| mild hepatic impairment | Experimental | Subjects with mild hepatic impairment Receives: Drug: TPN171H |
| moderate hepatic impairment | Experimental | Subjects with mild moderate impairment Receives: Drug: TPN171H |
| healthy volunteers | Experimental | Subjects with normal hepatic function Receives: Drug: TPN171H |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Maximum Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients
Measured: 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
Measured: 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
Measured: 72 hours after dosing
Secondary outcomes (1)
Adverse events
Number of Participants With Adverse Events and Serious Adverse Events
Measured: From administration of study drug through 7 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 posted11 Jan 2022
- Study start16 Dec 2021
- Primary completion6 Feb 2022
- Study completion6 Feb 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 Erectile DysfunctionStudies 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
- 24 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
- Yan Hua Ding, MD, Study chair, The First Affiliated Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185011
- Sponsor's protocol ID
- TPN171H-09
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40277393
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of the Pharmacokinetics and Safety of TPN171H Tablets in Subjects With Mild Liver Insufficiency, Moderate Liver Insufficiency and Normal Liver Function
- ClinicalTrials.gov ID
- NCT05185011
- Acronym / sponsor ID
- TPN171H-09
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Institute of Materia Medica, Chinese Academy of Sciences
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 6 Feb 2022 (actual)
- Study completion
- 6 Feb 2022 (actual)
- First posted
- 11 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.
The study aims to investigate and compare the effect of TPN171H on subjects with mild and moderate hepatic impairment compared to healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild hepatic impairment | Experimental | Drug: TPN171HSubjects with mild hepatic impairment |
| moderate hepatic impairment | Experimental | Drug: TPN171HSubjects with mild moderate impairment |
| healthy volunteers | Experimental | Drug: TPN171HSubjects with normal hepatic function |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Hepatic Insufficiency Participants：
- Signing the informed consent forms；
- Take proper contraceptive during the study and within 6 months after the study completed;
- 18 years to 65 years (inclusive)；
- Male≥50kg，femal≥45kg, Body mass index should be between 18 and 30 kg/m2 (inclusive)；
Key exclusion criteria (22 listed)
- 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；
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 |
|---|---|---|
| TPN171H10 mg TPN171H tablets，single dose | Drug | healthy volunteers, mild hepatic impairment, moderate hepatic impairment |
Primary outcome
Maximum Plasma Concentration (Cmax)
Time frame: 72 hours after dosing
Maximum Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients
Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity（AUC0-∞）
Time frame: 72 hours after dosing
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
Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration （AUC0-t）
Time frame: 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） will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients
1 secondary outcome
Adverse events
Time frame: From administration of study drug through 7 days after administration of study drug
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 23 Mar 2022.
- Derived from this study: PubMed 40277393Zhou 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.
- Individual participant dataSharing planned: No
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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.
Yan Hua Ding, MD study chair
The First Affiliated Hospital of Jilin University
1 site 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 in people with Erectile Dysfunction and Pulmonary Arterial Hypertension, run by Vigonvita Life Sciences at 1 site 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 15 inclusion and 22 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 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Maximum Plasma Concentration (Cmax) (time frame: 72 hours after dosing). The study lists 3 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 NCT05185011, 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 23 Mar 2022.