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Pulmonary Arterial HypertensionPhase 1NCT05948644

The Safety, Tolerability, and Pharmacokinetics of TPN171H Tablets in Patients With Pulmonary Arterial Hypertension

A Phase 1 study testing TPN171H in people with Pulmonary Arterial Hypertension, run by Vigonvita Life Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Exploring the safety, tolerability, and pharmacokinetic (PK) characteristics of oral TPN171H tablets in patients with Pulmonary Arterial Hypertension under continuous multiple administration conditions, providing a basis for determining the administration plan and recommended dosage in phase II clinical study. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
TPN171H
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
8 Apr 2019to 14 Oct 2020
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who are able to signed the informed consent form ,understand and follow study plans and instructions;
  • Patients aged 18 to 75;
  • Patients with symptomatic PAH (Group1) with right heart catheterization results within the past 36 months (first category), a pulmonary vascular resistance (PVR) > 3 Wood, a mean pulmonary artery pressure (mPVP) ≥25 mmHg and a pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg ;
  • Patients have a current diagnosis of being in WHO functional class II or III;
  • Targeted therapeutic drugs were not added, discontinued, or dosed within 4 weeks prior to baseline; 6.6-MWD between 100m \&450m;
  • 7.Patients who are willing to take proper contraceptive during the study and within 3 months after the study completed.

Who cannot join

  • All types of PH except subtypes of Group1 specified in the inclusion criteria;
  • Patients who concomitant severe obstructive pulmonary disease(FEV1/FVC<0.5) ;
  • Total lung volume<60% predicted;
  • Systolic blood pressure below 90/60mmHg at screening;
  • Left ventricular ejection fraction less than 45%, left ventricular short axis shortening rate less than 0.2;
  • Lower limb diseases that affect the completion of 6-MWD testing;
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  • Subjects who received PDE5 inhibitors (such as sildenafil, tadalafil, vardenafil, and avanafil) within 4 weeks before baseline
  • CYP3A4 enzyme inducers (such as bosentan, aprepitant, barbiturates, carbamazepine, rifampicin, pioglitazone) or inhibitors (such as cimetidine, ciprofloxacin, boceprevir-d9，telaprevir, clarithromycin, nefazodone, and ritonavir) were taken within 2 months before the start of the trial, Regular or intermittent administration of nitrates (such as nitroglycerin, isosorbide nitrate,pentaerithrityl tetranitrate ) or any form of nitric oxide donor (including nicorandil, L-arginine) and α- Receptor blocking (such as phenoxybenzamine, prazosin, terazosin,tamsulosin)
  • Subjects with a clear history of allergic diseases or who have previously stopped taking either aniracetam or tadalafil due to safety or tolerable reasons;
  • Previous or current drug dependence, clear history of neurological or mental disorders, such as epilepsy, dementia, psychological or other emotional issues, may invalidate informed consent or limit the subject's ability to comply with the protocol;
  • Acute or chronic organic diseases (excluding breathing difficulties) prevent subjects from completing the necessary testing items required in the study (especially the 6-minute walking distance test);
  • Have a history of ophthalmic diseases, such as color vision abnormalities, retinitis pigmentosa, and macular degeneration;
  • Malignant tumor patients;
  • Moderate or severe liver function injury and/or blood ALT and AST exceeding 1.5 times the upper limit of normal values, and blood creatinine exceeding 1.5 times the upper limit of normal values;
  • Pathogenic test for HIV positive; Positive test for hepatitis B or hepatitis C; Subjects suffering from acute infectious diseases;
  • Suffered from infectious diseases recently (within 1 month);
  • The subject has ischemic heart disease (defined as symptomatic, requiring anti angina treatment, or having experienced myocardial infarction within the past 3 years);
  • Those who have experienced cerebrovascular events (such as transient ischemic attacks or strokes) within the past 3 months;
  • Participated in any clinical trial within 3 months prior to taking the investigational drug;
  • Pregnant or lactating women;
  • The researchers believe that subjects who are not suitable to participate in this experiment due to other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fu Zhu

    Shanghai

Other trials in China

About this study

Official title: Phase Ib Clinical Study on the Safety, Tolerability, and Pharmacokinetics of TPN171H Tablets in the Treatment of Pulmonary Arterial Hypertension (PAH) Patients

Exploring the safety, tolerability, and pharmacokinetic (PK) characteristics of oral TPN171H tablets in patients with Pulmonary Arterial Hypertension under continuous multiple administration conditions, providing a basis for determining the administration plan and recommended dosage in phase II clinical study.

Read the detailed description

This study was divided into screening period, treatment period and medication follow-up period, and the treatment period included 3 cycles.

First cycle: subjects receiving the test drug 2.5mg QD for 2 consecutive weeks, PK blood collection on Day 1 and Day 7, and the subjects discharged and returned to the hospital on Day 14 for medication monitoring blood collection, safety examination and efficacy assessment.

Second cycle: up to 14 weeks; the second cycle is divided into monitoring and observation cycles; subjects who complete the first cycle and examinations enter the second cycle, with a 14 day monitoring period and 12 week observation period, with the second cycle dose of 5 mg QD, subjects received PK sampling on Day 7.

Third cycle:The third cycle lasts for 8 days, subjects receive 10mg QD for 8 days; subjects received PK sampling on Day 7; subjects who completed an 8-day safety observation period on Day 8 without abnormal safety tests may be discharged. After discharge into the medication follow-up period.

Medication follow-up period: up to 2 years; subjects entering the follow-up period will continue to take the dose of the last treatment period, return to hospital once every 12 weeks for safety examination and efficacy assessment until the subject intolerance or withdrawal from the study or expiration of 2 years (whichever occurs first).

Being tested
TPN171H
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TPN171HDrug

    TPN171H 2.5mg TPN171H 5mg TPN171H 10mg

Study groups in NCT05948644
Study groupRoleWhat they receive
TPN171HExperimentalTPN171H is received 2.5mg QD for 2 consecutive weeks, then 5 mg QD for 14 consecutive weeks. If the dose is well-tolerated,TPN171H is up-titrated to 10mg QD , which will last for up to 2 years.
Receives: Drug: TPN171H

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events

    Measured: through study completion, an average of 2 years

  2. Q-T interval

    Measured: through study completion, an average of 2 years

  3. Tmax

    Measured: From time zero up to 24 hours post-dose following oral administration of TPN171H

  4. Cmax

    Measured: From time zero up to 24 hours post-dose following oral administration of TPN171H

  5. AUC0~t

    Measured: From time zero up to 24 hours post-dose following oral administration of TPN171H

  6. AUC0-∞

    Measured: From time zero up to 24 hours post-dose following oral administration of TPN171H

  7. Terminal half-life (t 1/2)

    Measured: From time zero up to 24 hours post-dose following oral administration of TPN171H

  8. Apparent distribution volume (Vd/F)

    Measured: From time zero up to 24 hours post-dose following oral administration of TPN171H

  9. Clearance rate (CL/F)

    Measured: From time zero up to 24 hours post-dose following oral administration of TPN171H

  10. Mean Residence Time(MRT)

    Measured: From time zero up to 24 hours post-dose following oral administration of TPN171H

Secondary outcomes (4)

  1. 6- Minute Walk Distance（6-MWD）

    Cardiopulmonary function indicators reflecting the patient's physiological state

    Measured: through study completion, an average of 2 years

  2. NT-proBNP

    Heart failure evaluation indicators to evaluate the severity of heart failure;

    Measured: through study completion, an average of 2 years

  3. The World Health Organization (WHO) functional class

    Evaluate the severity of Pulmonary Arterial Hypertension symptoms at each time point before and after taking TPN171H

    Measured: through study completion, an average of 2 years

  4. Borg dyspnea index

    to evaluate the degree of difficulty breathing in subjects after a 6-minute walk test

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2023
  2. Study start8 Apr 2019
  3. Primary completion14 Oct 2020
  4. Study completion14 Oct 2020

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05948644
Sponsor's protocol ID
TPN171H-04
Status last verified
Jun 2023
First submitted
21 Jun 2023
Last updated
13 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TPN171H in people with 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 6 inclusion and 21 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 13 Oct 2023. 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?

Incidence of Treatment-Emergent Adverse Events (time frame: through study completion, an average of 2 years). The study lists 10 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 NCT05948644.

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 13 Oct 2023.

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