Safety and Pharmacokinetics of a Single Oral TPN171H in Healthy Elderly Subjects

A Phase 1 study testing TPN171H in people with Erectile Dysfunction, 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.

Trial summary

It is a single-center, open-label, Phase I clinical study evaluating the safety and pharmacokinetics of a single oral TPN171H in elderly subjects. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Erectile Dysfunction
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: 12 participants
Where: 1 siteChina
Study dates: 14 Sep 2020to 22 Jul 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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

≥ 65 years old；
Male≥50kg，femal≥45kg, Body mass index should be between 18 and 30 kg/m2 (inclusive)；
No major organ dysfunction；normal heart, liver and kidney function;
Physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry), 12 lead ECG, Abdominal ultrasound, chest X-ray results were normal or abnormal but investigator judged suitable for participating in this trial;
Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent

Who cannot join

Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases;
Surgical condition or condition that may significantly affect ADME of the drug, urgical condition or condition that may pose a hazard if the subject participating in the study
Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, congestive heart failure, severe arrhythmias, cerebrovascular accidents, including transient ischemic attack within 3 months before inclusion;
Taken any of drugs(Inhibits or induces liver metabolism) within 2 weeks before inclusion；administered with Nitrate/Nitric oxide (NO) donors。
With a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinopathy (e.g. Retinitis pigmentosa), and macular degeneration；
A history of sudden decrease or loss of hearing；

Show all 14Show fewer

A history of postural hypotension；
Blood loss ≥400 mL within 3 months before inclusion；
Participated in other drug clinical trials or medical devices clinical trials within 3 months before administration；
Drink alcohol at least 2 times a day or more than 14 times a week in the 6 months prior to enrollment or alcoholics(Drink alcoholics defined as 125 mL of wine, 220 mL of beer, or liquor50mL； Alcoholism is defined as 5 or more drinks in approximately 2 hours) ;
A history of drug use or have been screened positive for drug abuse;
Smoked more than 10 cigarettes a day within 6 months prior to inclusion;
hepatitis B surface antigen (HBsAg),hepatitis C virus antibody,treponema pallidum antibody,Human immunodeficiency virus antibody (HIV)positive;
Other factors that the investigator considered inappropriate for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031

Other trials in China

About this study

Official title: A Study Evaluating Safety and Pharmacokinetics of a Single Oral TPN171H in Elderly Subjects

It is a single-center, open-label, Phase I clinical study evaluating the safety and pharmacokinetics of a single oral TPN171H in elderly subjects.

Conditions: Erectile Dysfunction
Being tested: TPN171H
Medical subject headings: Erectile Dysfunction

What participants receive

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

TPN171HDrug
5 mg TPN171H tablets，single dose,oral

Study groups in NCT06090136
Study group	Role	What they receive
TPN171H	Experimental	5 mg TPN171H tablets，single dose,oral Receives: Drug: TPN171H

What is being measured

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

Adverse events
Number of Participants With treatment-related Adverse Events and Serious Adverse Events
Measured: 7 days after dosing
Pharmacokinetic parameter of TPN171H:Tmax
Pharmacokinetic parameter of TPN171H:Tmax
Measured: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:Cmax
Pharmacokinetic parameter of TPN171H:Cmax
Measured: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:T1/2
Pharmacokinetic parameter of TPN171H:T1/2
Measured: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:AUC0-t
Pharmacokinetic parameter of TPN171H:AUC0-t
Measured: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:AUC0-∞
Pharmacokinetic parameter of TPN171H:AUC0-∞
Measured: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:AUC0-24h
Pharmacokinetic parameter of TPN171H:AUC0-24h
Measured: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:Ke
Pharmacokinetic parameter of TPN171H:Ke
Measured: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:Vd
Pharmacokinetic parameter of TPN171H:Vd
Measured: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:MRT
Pharmacokinetic parameter of TPN171H:MRT
Measured: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:CL/F
Pharmacokinetic parameter of TPN171H:CL/F
Measured: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:BRPP
Pharmacokinetic parameter of TPN171H:BRPP
Measured: 48 hours after dosing

Timeline

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

14 Sep 202022 Jul 2022

First posted19 Oct 2023
Study start14 Sep 2020
Primary completion14 Dec 2020
Study completion22 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06090136
Sponsor's protocol ID: TPN171H-06
Status last verified: Oct 2023
First submitted: 21 Jun 2023
Last updated: 19 Oct 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Erectile Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study Evaluating Safety and Pharmacokinetics of a Single Oral TPN171H in Elderly Subjects
ClinicalTrials.gov ID: NCT06090136
Acronym / sponsor ID: TPN171H-06
Conditions: Erectile Dysfunction
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Vigonvita Life SciencesIndustry (pharma, biotech, devices)
Study start: 14 Sep 2020 (actual)
Primary completion: 14 Dec 2020 (actual)
Study completion: 22 Jul 2022 (actual)
First posted: 19 Oct 2023 (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.

It is a single-center, open-label, Phase I clinical study evaluating the safety and pharmacokinetics of a single oral TPN171H in elderly subjects.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TPN171H	Experimental	Drug: TPN171H5 mg TPN171H tablets，single dose,oral

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

≥ 65 years old；
Male≥50kg，femal≥45kg, Body mass index should be between 18 and 30 kg/m2 (inclusive)；
No major organ dysfunction；normal heart, liver and kidney function;
Physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry), 12 lead ECG, Abdominal ultrasound, chest X-ray results were normal or abnormal but investigator judged suitable for participating in this trial;
Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent

Key exclusion criteria (14 listed)

Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases;
Surgical condition or condition that may significantly affect ADME of the drug, urgical condition or condition that may pose a hazard if the subject participating in the study
Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, congestive heart failure, severe arrhythmias, cerebrovascular accidents, including transient ischemic attack within 3 months before inclusion;
Taken any of drugs(Inhibits or induces liver metabolism) within 2 weeks before inclusion；administered with Nitrate/Nitric oxide (NO) donors。
With a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinopathy (e.g. Retinitis pigmentosa), and macular degeneration；

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
TPN171H5 mg TPN171H tablets，single dose,oral	Drug	TPN171H

Primary outcome

Adverse events
Time frame: 7 days after dosing
Number of Participants With treatment-related Adverse Events and Serious Adverse Events
Pharmacokinetic parameter of TPN171H:Tmax
Time frame: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:Tmax
Pharmacokinetic parameter of TPN171H:Cmax
Time frame: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:Cmax
Pharmacokinetic parameter of TPN171H:T1/2
Time frame: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:T1/2
Pharmacokinetic parameter of TPN171H:AUC0-t
Time frame: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:AUC0-t
Pharmacokinetic parameter of TPN171H:AUC0-∞
Time frame: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:AUC0-∞
Pharmacokinetic parameter of TPN171H:AUC0-24h
Time frame: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:AUC0-24h
Pharmacokinetic parameter of TPN171H:Ke
Time frame: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:Ke
Pharmacokinetic parameter of TPN171H:Vd
Time frame: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:Vd
Pharmacokinetic parameter of TPN171H:MRT
Time frame: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:MRT
Pharmacokinetic parameter of TPN171H:CL/F
Time frame: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:CL/F
Pharmacokinetic parameter of TPN171H:BRPP
Time frame: 48 hours after dosing
Pharmacokinetic parameter of TPN171H:BRPP

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 19 Oct 2023.
Individual participant dataSharing planned: No

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Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
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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.

Gangyi Liu principal investigator

Xuhui Central Hospital, Shanghai

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, 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 5 inclusion and 14 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 19 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?

Adverse events (time frame: 7 days after dosing). The study lists 12 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 NCT06090136.

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 19 Oct 2023.