Pharmacokinetics of Y-4 Tablets With Pregabalin Capsules and Riluzole Tablets in U.S. Healthy Participants

NCT07618715 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: Y-4-LC-02 (US)
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this clinical trial is to compare pharmacokinetic characteristics of Y-4 tablets with pregabalin capsules and riluzole tablets in the US healthy adult participants after single oral administration under fasted condition. The secondary goal of the trial is to evaluate the safety and tolerability of Y-4 tablets, pregabalin capsules and riluzole tablets in the US healthy adult participants.

Conditions

Healthy Male and Female Subjects

Keywords

Phase Ⅰ; Y-4 Tablet; Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum observed concentration, it was obtained directly from the measured plasma concentration-time data;

  On Day1-4、Day8-11、Day15-18 of observation period.

• AUC0-t

  Area under the concentration-time curve from time zero to the last detectable concentration

  On Day1-4、Day8-11、Day15-18 of observation period.

• AUC0-∞

  Area under the concentration-time curve from time 0 to infinity (extrapolated).

  On Day1-4、Day8-11、Day15-18 of observation period.

Secondary Outcomes (15)

• Tmax

  On Day1-4、Day8-11、Day15-18 of observation period.

• λz

  On Day1-4、Day8-11、Day15-18 of observation period.

• t1/2

  On Day1-4、Day8-11、Day15-18 of observation period.

• CL/F

  On Day1-4、Day8-11、Day15-18 of observation period.

• Vz/F

  On Day1-4、Day8-11、Day15-18 of observation period.

Study Arms (3)

Y-4 tables

EXPERIMENTAL

In the morning of Day 1 ，single oral administration one Y-4 tablet in the state of fasting state.

Drug: Y-4 tablet

Pregabalin capsule

EXPERIMENTAL

In the morning of Day 8 ，single oral administration one pregabalin capsule in the state of fasting state.

Drug: Pregabalin capsule

Riluzole tablet

EXPERIMENTAL

In the morning of Day 15 ，single oral administration one riluzole tablet in the state of fasting state.

Drug: Riluzole tablet

Interventions

Y-4 tablet DRUG

Participants will be admitted to research center on Day-1. Participants are required to fast for at least 10 hours prior to dosing on Day 1. In the morning of Day 1, participants will be administered with one tablet of Y-4 (pregabalin 112.5 mg and riluzole 28.125 mg), then participants will be monitored and blood samples will be collected for the following 72 hours (Day4).

Y-4 tables

Pregabalin capsule DRUG

Participants are required to fast for at least 10 hours prior to dosing on Day 8. In the morning of Day 8, participants will be administered with one pregabalin capsule (75 mg pregabalin), then participants will be monitored and blood samples will be collected for the following 72 hours (Day 11).

Pregabalin capsule

Riluzole tablet DRUG

Participants are required to fast for at least 10 hours prior to dosing on Day 15. In the morning of Day 15, participants will be administered with one riluzole tablet (50 mg riluzole), then participants will be monitored and blood samples will be collected for the following 72 hours (Day 18).

Riluzole tablet

Eligibility Criteria

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

You may qualify if:

• Healthy adult male and female participants, 18-45 years of age (including both ends).
• Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) within the range of 19 - 28 kg/m2 (including both ends).
• During the screening period, serum creatinine is within the normal range, or the standard creatinine clearance (CLcr) estimated by Cockcroft-Gault formula is ≥ 80 mL/min (for female participant, according to the calculation result × 0.85）
• Participants who are able to understand and give their signed informed consent before any trial related procedures are performed.

You may not qualify if:

• Participants who are known to be allergic to pregabalin, riluzole or any excipients of Y-4 tablets (microcrystalline cellulose, copovidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry amb Ⅱ), have allergic diseases or allergic constitution;
• Participants who have special requirements for diet and cannot follow the unified diet;
• Physical examinations, vital signs, 12-lead electrocardiograms (ECG), laboratory tests (Hematology, serum chemistry, coagulation test, urinalysis, etc.) and other screening tests found abnormalities that the researchers judged to be of clinical significance;
• Participants who have experienced angioedema in the past (such as swelling of the face, mouth (tongue, lips, and gums), and neck (pharynx and throat));
• History of dizziness or vertigo with clinical significance, or disease of inner ear known to cause dizziness or vertigo;
• QTcF \> 450 msec at the screening stage (Corrected using Fridericia's formula: QTcF = QT /(RR\^0.33), where RR = 60 / heart rate);
• Diagnosed with insomnia, anxiety disorder, depression, epilepsy, or other serious mental disorders, and principal investigator determines that the participant is not suitable to participate in this trial;
• Presence or history of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of medicines, participants who have impaired hepatic function at the time of screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 ULN; or total bilirubin (TBIL) \> 1.0 ULN;
• Participants who drink too much tea, coffee and/or caffeine-containing beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months prior to screening, or disagree that any caffeine-containing beverages are prohibited during the trial;
• Participants who have consume any diet (food or beverage) rich in grapefruit, pitaya, mango and cranberry within 14 days prior to screening;
• Participants have disease history or current disease that may affect the safety evaluation of the participant or the internal process of the study drug, including the central nervous system, cardiovascular system, digestive system, endocrine system, respiratory system, urinary system, hematological system, immunology, psychiatry, metabolic abnormalities, gastrointestinal surgery (excluding appendicitis surgery), etc. In particular, there is a history of dysphagia or any gastrointestinal disease affecting drug absorption (including frequent nausea or vomiting caused by any cause) and eye diseases;
• Donation or loss of blood equal to or in excess of 400 mL, or blood transfusion within 3 months prior to screening; or donation or loss of blood equal to or in excess of 200 mL within 1 month prior to screening;
• Participants who have taken any drugs known to be strong inhibitors or inducers of cytochrome P450 enzymes within 2 months prior to screening (such as inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - serotonin reuptake inhibitors (SSRI) antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines); or participants who have taken any prescription drugs, over-the-counter drugs and traditional Chinese medicine or herbal medicine other than the above drugs within 14 days prior to screening;
• Participants who have taken central nervous system (CNS) depressants including opioids (pethidine hydrochloride, morphine, dihydromorphine hydrochloride, fentanyl, Tramadol, etc), benzodiazepines (diazepam, flurazepam, clonazepam, oxazepam, chlordiazepine and triazolam etc), antiepileptic drugs (carbamazepine, sodium valproate, phenobarbital drugs etc) within 2 months prior to screening;
• Participant with sleep apnea, or participants with severe sleep snoring and daytime drowsiness;

Sponsors & Collaborators

• Neurodawn Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Frontage Clinical Services,Inc.

Secaucus, New Jersey, 07094, United States

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Pregabalin; Riluzole

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Frank Lee

CONTACT

(201)416-7753; flee@frontagelab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 1, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)