Drug Interaction Study on Linaprazan Glurate Capsules

NCT07294846 | Completed Phase 1

• 1 other identifier: SND-X842-103
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a drug-drug interaction (DDI) investigation involving Linaprazan Glurate capsules and a combination of clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules. The study plan is divided into two parts: one involving Hp-negative healthy subjects and the other involving Hp-positive subjects.

Conditions

Healthy Volunteers; Patients

Keywords

Potassium competitive acid blocker; Acid inhibition; Adjunctive therapy for H. pylori eradication; PK; Linaprazan Glurate Capsules

Outcome Measures

Primary Outcomes (16)

• Steady state maximum concentration (Cmax,ss)

  Cmax,ss of of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.

  7 days

• AUC0-τ,ss(The area under the drug-time curve within the dosing interval after reaching the steady state)

  AUC0-τ,ss of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.

  7 days

• Cav,ss (Average steady-state blood drug concentration)

  Cav,ss of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.

  7 days

• Tmax,ss (Steady-state peak time)

  Tmax,ss of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.

  7 days

• CLss/F(Steady-state apparent clearance rate)

  CLss/F of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.

  7 days

• t1/2z(Terminal elimination half-life)

  t1/2z of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study; and t1/2z of Pharmacokinetic Parameters of Bismuth in Part 2 study.

  7, 14 days

• Vz/F (Apparent volume of distribution in the terminal elimination phase)

  Vz/F of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study; and Vz/F of Pharmacokinetic Parameters of Bismuth in Part 2 study.

  7, 14 days

• λz (Terminal elimination rate constant)

  λz of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study; and λz of Pharmacokinetic Parameters of Bismuth in Part 2 study.

  7, 14 days

• MRT(mean residence time)

  MRT of Linaprazan Glurate and its active metabolite(s), clarithromycin and its active metabolite(s), and amoxicillin in Part 1 study.

  7 days

• Cmax(Maximum observed plasma drug concentration)

  Cmax of Pharmacokinetic Parameters of Bismuth in Part 2 study.

  14 days

• AUC0-τ (The area under the drug-time curve within the dosing interval)

  AUC0-τ of Pharmacokinetic Parameters of Bismuth in Part 2 study.

  14 days

• Tmax (Time to reach maximum plasma concentration)

  Tmax of Pharmacokinetic Parameters of Bismuth in Part 2 study.

  14 days

• CL/F (apparent clearance)

  CL/F of Pharmacokinetic Parameters of Bismuth in Part 2 study.

  14 days

• Ae0-τ (Amount of drug excreted in urine over the dosing interval)

  Ae0-τ of Pharmacokinetic Parameters of Bismuth in Part 2 study.

  14 days

• fe (Amount of drug excreted in urine over the dosing interval)

  fe of Pharmacokinetic Parameters of Bismuth in Part 2 study.

  14 days

• CLR (renal clearance)

  CLR of Pharmacokinetic Parameters of Bismuth in Part 2 study.

  14 days

Secondary Outcomes (4)

• The percentage of time over a 24-hour period that intragastric pH ≥ 4 and pH ≥ 6

  1, 14 days

• Proportion of subjects with successful Helicobacter pylori (Hp) eradication

  1, 14 days

• Number of subjests With Adverse Events

  up to 56 days

• Number of subjests With Clinically Notable Electrocardiogram (ECG) Values

  up to 56 days

Study Arms (3)

Linaprazan Glurate Capsules 50mg BID, consecutive 7-day dosing per period

EXPERIMENTAL

Glurate Capsules Capsules 50mg, BID, consecutive 7-day dosing per period in Part 1.

Drug: Linaprazan Glurate Capsules; Drug: Amoxicillin Capsules; Drug: Clarithromycin tablets

Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing

EXPERIMENTAL

Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing in part 2.

Drug: Linaprazan Glurate Capsules; Drug: Bismuth Potassium Citrate Capsules; Drug: Amoxicillin Capsules; Drug: Clarithromycin tablets

Esomeprazole Magnesium Enteric-coated Tablets 20mg BID, consecutive 14-day dosing.

EXPERIMENTAL

Esomeprazole Magnesium Enteric-coated Tablets 20mg, BID in Part 2.

Drug: Bismuth Potassium Citrate Capsules; Drug: Amoxicillin Capsules; Drug: Clarithromycin tablets; Drug: Esomeprazole Magnesium Enteric-coated Tablets

Interventions

Linaprazan Glurate Capsules DRUG

Linaprazan Glurate capsules

Also known as: Linaprazan Glurate

Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing; Linaprazan Glurate Capsules 50mg BID, consecutive 7-day dosing per period

Bismuth Potassium Citrate Capsules DRUG

Bismuth Potassium Citrate Capsules

Also known as: Bismuth Potassium Citrate

Esomeprazole Magnesium Enteric-coated Tablets 20mg BID, consecutive 14-day dosing.; Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing

Amoxicillin Capsules DRUG

Amoxicillin Capsules

Also known as: Amoxicillin

Esomeprazole Magnesium Enteric-coated Tablets 20mg BID, consecutive 14-day dosing.; Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing; Linaprazan Glurate Capsules 50mg BID, consecutive 7-day dosing per period

Clarithromycin tablets DRUG

Clarithromycin Tablets

Also known as: Clarithromycin

Esomeprazole Magnesium Enteric-coated Tablets 20mg BID, consecutive 14-day dosing.; Linaprazan Glurate Capsules 50mg BID, consecutive 14-day dosing; Linaprazan Glurate Capsules 50mg BID, consecutive 7-day dosing per period

Esomeprazole Magnesium Enteric-coated Tablets DRUG

Esomeprazole Magnesium Enteric-coated Tablets

Also known as: Esomeprazole Magnesium

Esomeprazole Magnesium Enteric-coated Tablets 20mg BID, consecutive 14-day dosing.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range: 18 to 55 years old (including 18 and 55);
• Male weight ≥50.0 kg, female weight ≥45.0 kg; Body Mass Index (BMI) between 19.0 and 26.0 kg/m²(including critical value); BMI=weight/height2 (m2)
• Part 1 Study and Part 2 Study:
• Part 1: Subjects must be Helicobacter pylori-negative at screening; Part 2: Subjects must be Helicobacter pylori-positive at screening;
• From signing informed consent until 3 months after study completion, subjects must: Implement appropriate and effective contraception to prevent pregnancy (applies to subject or partner); Refrain from sperm donation or egg donation plans;
• Subjects must fully comprehend the trial content, voluntarily participate in the trial, Provide written informed consent;

You may not qualify if:

• Subjects known as Hypersensitivity History: Known allergy to: Linaprazan Glurate capsules, Esomeprazole (Part 2 only), Penicillin, Macrolide antibiotics, Any component of bismuth potassium citrate;History of severe immediate hypersensitivity to: Other macrolide antibiotics, β-lactam agents (e.g., cephalosporins, carbapenems, monobactams),Multiple drug hypersensitivity (e.g., allergic reactions to ≥2 medications/foods);
• Clinically Significant Abnormalities at Screening: Abnormalities deemed clinically significant by investigators based on: Medical history review, Vital signs, Physical examination, 12-lead ECG, Laboratory tests: Complete blood count (CBC), Blood chemistry, Urinalysis, Coagulation tests ;
• Subjects with Penicillin sodium skin test positivity during screening;
• Subjects with use of any investigational product within 3 months prior to screening;
• Subjects with use of potassium-competitive acid blockers (P-CABs) within 3 months prior to screening;
• Subjects with use within 30 days prior to screening of Prescription drugs, Over-the-counter ,OTC) medications, Herbal medicines, Dietary supplements;
• Subjects with history of diseases in the following systems (also investigator-determined as ineligible): Central nervous system, Cardiovascular system, Respiratory system, Digestive system, Endocrine system, Immune system, Neurological/Psychiatric systems, Hematologic/Lymphatic systems, Musculoskeletal system;
• Gastrointestinal/Surgical History: History of gastrointestinal diseases or surgeries including:Gastric surgery (except pyloromyotomy for infantile pyloric stenosis), Cholecystectomy, Vagotomy, Bowel resection, Any surgery potentially affecting GI motility, pH, or absorption, Conditions impacting drug ADME: Dysphagia, Vomiting, Severe diarrhea;
• Cardiac Abnormalities: Clinically significant ECG abnormality history, Family history of Long QT Syndrome (grandparents, parents, siblings), Screening QTcF prolongation: 450 msec in males, 470 msec in females;
• Subjects with major surgery within 3 months prior to screening,and planned surgery during trial participation;
• Subjects with blood donation (whole blood/component) ≥400 mL within 3 months (excluding menstrual loss),Blood transfusion or blood product use within 3 months;
• Infectious Disease Screening: Positive results for any at screening: Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), Treponema pallidum antibody (TP-Ab);
• Subjects who have used illicit drugs within the 3 months prior to screening, or have a history of drug abuse within the past 12 months, or whose urine drug abuse screening test result is positive;
• Subjects who regularly consumed alcohol within the 3 months prior to screening (i.e., consuming more than 14 standard units per week; 1 unit = 360mL of beer, or 45mL of 40% spirits, or 150mL of wine), or who are unwilling to abstain from alcohol or any alcohol-containing products for 48 hours prior to dosing and during the trial, or whose alcohol breath test result is positive;
• Subjects who smoked an average of \>5 cigarettes per day within the 30 days prior to screening; or who cannot guarantee abstinence from smoking from the signing of the informed consent form until the end of the study;

Sponsors & Collaborators

• Jiangsu Sinorda Biomedicine Co., Ltd: lead

Study Sites (1)

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

Location

MeSH Terms

Interventions

Amoxicillin; Clarithromycin; Esomeprazole

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Officials

• Ming Lu

  Shanghai Sinorda Biomedicine Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study investigates the drug-drug interactions (DDI) among Linaprazan Glurate capsules, clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules. The research plan is divided into two parts: a study in Hp-negative healthy subjects and a study in Hp-positive subjects.

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: December 19, 2025
• Study Start: September 8, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

CN (1)