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

NCT05750355 | Completed Phase 1

• 1 other identifier: TPN171H-11
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 Chinese subjects after a single oral administration.

Conditions

Healthy Subjects

Keywords

TPN171H tablets; QT/QTc Intervals

Outcome Measures

Primary Outcomes (1)

• QT Interval Corrected Using Fridericia's Formula

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

  From Day 1 to Day3

Secondary Outcomes (15)

• QT Interval

  From Day 1 to Day3

• Corrected QT interval

  From Day 1 to Day3

• PR interval

  From Day 1 to Day3

• RR interval

  From Day 1 to Day3

• QRS duration

  From Day 1 to Day3

Study Arms (2)

TPN171H

EXPERIMENTAL

Subjects will receive TPN171H orally for single dose

Drug: TPN171H 10 mg Group; Drug: TPN171H 30 mg Group; Drug: TPN171H 40 mg Group; Drug: TPN171H 50 mg Group

Placebo

PLACEBO COMPARATOR

Subjects will receive Placebo orally for single dose

Drug: TPN171H 10 mg Group; Drug: TPN171H 30 mg Group; Drug: TPN171H 40 mg Group; Drug: TPN171H 50 mg Group

Interventions

TPN171H 10 mg Group DRUG

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

Also known as: TPN171H 10 mg

Placebo; TPN171H

TPN171H 30 mg Group DRUG

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

Also known as: TPN171H 30 mg

Placebo; TPN171H

TPN171H 40 mg Group DRUG

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

Also known as: TPN171H 40 mg

Placebo; TPN171H

TPN171H 50 mg Group DRUG

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

Also known as: TPN171H 50 mg

Placebo; TPN171H

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Huashan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 201900, China

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Jing Zhang

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: March 1, 2023
• Study Start: October 10, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

CN (1)