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Healthy SubjectsPhase 1NCT05750355

Evaluate the Effect of TPN171H on the QT/QTc Interval in Healthy Volunteers

A Phase 1 study testing TPN171H 10 mg Group, TPN171H 30 mg Group and TPN171H 40 mg Group in people with Healthy Subjects, 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

This is a single-dose orally administered, dose-escalation, single-center, randomized, double-blind, placebo-parallel controlled clinical study evaluating the effect of TPN171H tablets on QT/QTc interval in healthy subjects.The main objective was to evaluate the effect of TPN171H tablets on QT/QTc interval in healthy… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
TPN171H 10 mg Group, TPN171H 30 mg Group and TPN171H 40 mg Group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteChina
Study dates
10 Oct 2022to 7 Dec 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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 18-45 years old, both male and female;
  • Weight: male ≥ 50 kg, female ≥ 45 kg, 19 kg/m2 ≤ BMI ≤26 kg/m2
  • Three 12-lead ECG examinations (the average of three measurements will be used to determine eligibility), QTcF≤450 ms, PR interval ≤200 ms, and QRS duration <120 ms;
  • Reliable contraceptive measures will be taken from the signing of the informed consent to 3 months after the medication, and there is no plan to donate sperm or eggs. The specific contraceptive measures are detailed in the appendix.
  • Able to understand the procedures and methods of this trial, willing to strictly abide by the clinical trial protocol to complete this trial, and voluntarily sign the informed consent.

Who cannot join

  • Known allergic history to the investigational drug and any of its components or related preparations;
  • People with allergic diseases, food allergies or allergic constitutions;
  • have a history of risk factors for torsdos de pointes, or have a family history of short QT syndrome, long QT syndrome, unexplained sudden death in young adulthood (≤40 years old), drowning or sudden infant death syndrome in first-degree relatives (i.e., biological parents, siblings or children);
  • Previous history of hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia;
  • Those who have definite diseases of the central nervous system, cardiovascular system, digestive system (including those with moderate or severe fatty liver on B-ultrasound examination), respiratory system, urinary system, blood system, and metabolic disorders that require medical intervention or other diseases that are not suitable for clinical trials (such as psychiatric history, etc.);
  • Patients with blurred vision or history of ophthalmology (such as abnormal color vision, retinitis pigmentosa, macular degeneration);
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  • Patients with a history of postural hypotension;
  • Patients with a history of acute respiratory infection or acute illness within 14 days before screening;
  • Those who had donated blood or lost ≥400 mL of blood within 3 months before screening;
  • Use of any drugs that inhibit or induce liver metabolism of drugs (such as: inducers - barbiturates, carbazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors -SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazole, sedatives and hypnotics, verapamil, fluoroquinolones, antihistamines);
  • Those who have taken any prescription drugs, non-prescription drugs, health care products, vitamins and Chinese herbal medicines within 14 days before screening;
  • Consuming grapefruit, grapefruit, pitaya, mango and other fruits or related products that affect metabolic enzymes within 7 days before screening;
  • Intake of caffeine-rich or xanthine-rich beverages or foods (such as coffee, strong tea, chocolate, cola, etc.) within 48 h before screening;
  • Those who participated in other drug clinical trials within 3 months before screening;
  • Current or former drug users or alcohol addicts, current or former alcoholics (drinking more than 14 standard units per week). 1 standard unit containing 14g of alcohol (e.g. 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or a positive breath test for alcohol;
  • Those who smoked more than 10 cigarettes per day in the previous 3 months were screened;
  • Physical examination, abnormal vital signs (ear temperature >37.5℃, respiratory rate >20 beats/minute, pulse rate >100 beats/minute, systolic blood pressure ≥140 mmHg or <90 mmHg, diastolic blood pressure ≥90 mmHg or <50 mmHg), abnormal and clinically significant laboratory results, and those who have an impact on the evaluation of this trial;
  • Laboratory tests showed that serum potassium, magnesium and calcium were beyond the normal range and the abnormalities were judged by the researchers to be clinically significant;
  • Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, syphilis antibody (TPPA) or human immunodeficiency virus (HIV) antibody positive;
  • Abnormal chest X-ray (anteroposterior and lateral view) or lung CT results with clinical significance;
  • Women with positive blood pregnancy test (applicable to women) or lactating women;
  • Those who have other factors that the investigator considers unsuitable for participation in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital affiliated to Fudan University

    Shanghai, Shanghai Municipality, 201900

Other trials in China

About this study

Official title: A Single-dose-oral, Ascending-Dose, Single-Center,Randomized, Double-Blind, Placebo-Parallel-controlled Study for the Evaluation of the Effect of TPN171H Tablets on the QT/QTc Intervals in Adult Healthy Subjects

This is a single-dose orally administered, dose-escalation, single-center, randomized, double-blind, placebo-parallel controlled clinical study evaluating the effect of TPN171H tablets on QT/QTc interval in healthy subjects.The main objective was to evaluate the effect of TPN171H tablets on QT/QTc interval in healthy Chinese subjects after a single oral administration.

Read the detailed description

This trial was a single-center, randomized, double-blind, placebo parallel controlled trial of TPN171H tablets with single oral administration, dose escalation, in healthy Chinese subjects.

This trial plans to set up 4 dose groups, and a total of 32 healthy adult subjects are expected to be enrolled. All subjects will receive a single oral dose under fasting state, and complete 3 days of PK blood sampling, 12-lead ECG examination and other safety checks. The trial was sequential according to the principle of dose escalation, that is, the next dose group was tested on the premise that the safety and tolerability of the previous group were good.

Being tested
TPN171H 10 mg Group, TPN171H 30 mg Group, TPN171H 40 mg Group, TPN171H 50 mg Group
Keywords
TPN171H tablets, QT/QTc Intervals

What participants receive

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

  • TPN171H 10 mg GroupDrug

    Also called TPN171H 10 mg

    6 subjects will receive TPN171H 10 mg, orally; 2 subjects will receive placebo, orally.

  • TPN171H 30 mg GroupDrug

    Also called TPN171H 30 mg

    6 subjects will receive TPN171H 30 mg, orally; 2 subjects will receive placebo, orally.

  • TPN171H 40 mg GroupDrug

    Also called TPN171H 40 mg

    6 subjects will receive TPN171H 40 mg, orally; 2 subjects will receive placebo, orally.

  • TPN171H 50 mg GroupDrug

    Also called TPN171H 50 mg

    6 subjects will receive TPN171H 50 mg, orally; 2 subjects will receive placebo, orally.

Study groups in NCT05750355
Study groupRoleWhat they receive
TPN171HExperimentalSubjects will receive TPN171H orally for single dose
Receives: Drug: TPN171H 10 mg Group; Drug: TPN171H 30 mg Group; Drug: TPN171H 40 mg Group; Drug: TPN171H 50 mg Group
PlaceboPlacebo comparatorSubjects will receive Placebo orally for single dose
Receives: Drug: TPN171H 10 mg Group; Drug: TPN171H 30 mg Group; Drug: TPN171H 40 mg Group; Drug: TPN171H 50 mg Group

What is being measured

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

  1. QT Interval Corrected Using Fridericia's Formula

    Model-guided placebo-corrected change in QTcF from baseline (ΔΔQTcF)

    Measured: From Day 1 to Day3

Secondary outcomes (15)

  1. QT Interval

    Change in QT interval from baseline

    Measured: From Day 1 to Day3

  2. Corrected QT interval

    Change in QTc interval from baseline

    Measured: From Day 1 to Day3

  3. PR interval

    Change in PR interval from baseline

    Measured: From Day 1 to Day3

  4. RR interval

    Change in RR interval from baseline

    Measured: From Day 1 to Day3

  5. QRS duration

    Change in QRS duration limit interval from baseline

    Measured: From Day 1 to Day3

  6. Heart rate

    Change in HR from baseline

    Measured: From Day 1 to Day3

  7. T-wave

    Whether the T-wave shape is abnormal

    Measured: From Day 1 to Day3

  8. U-wave

    Whether the U-wave shape is abnormal

    Measured: From Day 1 to Day3

  9. Number of participants with arrhythmic

    Number of participants with arrhythmic, arrhythmic includes Atrial fibrillation, atrial flutter, atrioventricular block, ST segment changes, etc

    Measured: From Day 1 to Day3

  10. Tmax

    time to peak

    Measured: From Day 1 to Day3

  11. Cmax

    maximum concentration

    Measured: From Day 1 to Day3

  12. plasma half-life（T1/2）

    Elimination half life

    Measured: From Day 1 to Day3

  13. Area under concentration-time curve (AUC0-t)

    Area under concentration-time curve (AUC0-t)

    Measured: From Day 1 to Day3

  14. Incidence of adverse events

    Incidence of adverse events

    Measured: From Day 1 to Day3

  15. Severity of adverse events

    Severity of adverse events

    Measured: From Day 1 to Day3

Timeline

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

  1. First posted1 Mar 2023
  2. Study start10 Oct 2022
  3. Primary completion7 Dec 2022
  4. Study completion7 Dec 2022

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05750355
Sponsor's protocol ID
TPN171H-11
Status last verified
Apr 2023
First submitted
6 Nov 2022
Last updated
5 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TPN171H 10 mg Group, TPN171H 30 mg Group and TPN171H 40 mg Group in people with Healthy Subjects, 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 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 5 Apr 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. Some participants in this study may receive a placebo. 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?

QT Interval Corrected Using Fridericia's Formula (time frame: From Day 1 to Day3). 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 NCT05750355.

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 5 Apr 2023.

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