A Study of the Pharmacokinetics and Safety of Anaprazole Sodium in Special Populations

NCT07345689 | Not Yet Recruiting Phase 4

• 1 other identifier: 3571-CPK-1008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the pharmacokinetic profile and safety of anaprazole sodium in adult subjects, particularly including the elderly and those with renal or hepatic impairment.

Conditions

Hepatic Insufficiency; Renal Insufficiency; Elderly

Outcome Measures

Primary Outcomes (7)

• Cmax

  Cmax of anaprazole sodium in healthy subjects and special participant populations.

  Up to 48 hours from anaprazole sodium administration

• Tmax

  Tmax of anaprazole sodium in healthy subjects and special participant populations.

  Up to 48 hours from anaprazole sodium administration

• AUC0-t

  AUC0-t of anaprazole sodium in healthy subjects and special participant populations.

  Up to 48 hours from anaprazole sodium administration

• AUC0-∞

  AUC0-∞of anaprazole sodium in healthy subjects and special participant populations.

  Up to 48 hours from anaprazole sodium administration

• t1/2

  t1/2 of anaprazole sodium in healthy subjects and special participant populations.

  Up to 48 hours from anaprazole sodium administration

• CL/F

  CL/F of anaprazole sodium in healthy subjects and special participant populations.

  Up to 48 hours from anaprazole sodium administration

• Vz/F

  Vz/F of anaprazole sodium in healthy subjects and special participant populations

  Up to 48 hours from anaprazole sodium administration

Secondary Outcomes (1)

• Number of Subjects With Adverse Events (AEs)

  Up to 7 days from the start of administration

Study Arms (5)

Healthy subjects

EXPERIMENTAL

Healthy subjects

Drug: Anaprazole Sodium enteric-coated tablet

Moderate hepatically impaired subjects

EXPERIMENTAL

Subjects with Child-Pugh B (score 7-9) at the screening visit

Drug: Anaprazole Sodium enteric-coated tablet

Moderate renal impaired subjects

EXPERIMENTAL

Subjects with eGFR 30-59 mL/min at the screening visit based on the Modification of Diet in Renal Disease (MDRD) equation

Drug: Anaprazole Sodium enteric-coated tablet

Severe renal impaired subjects

EXPERIMENTAL

Subjects with eGFR 15-29 mL/min at the screening visit based on the MDRD equation

Drug: Anaprazole Sodium enteric-coated tablet

Elderly subjects

EXPERIMENTAL

Elderly subjects (≥65 years old)

Drug: Anaprazole Sodium enteric-coated tablet

Interventions

Anaprazole Sodium enteric-coated tablet DRUG

20 mg single dose

Elderly subjects; Healthy subjects; Moderate hepatically impaired subjects; Moderate renal impaired subjects; Severe renal impaired subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form before any study-related activities commence, demonstrate an understanding of the trial procedures and methodology, and be willing to strictly adhere to the clinical trial protocol for study completion;
• Subjects (including their partners) must agree to have no plans for conception from screening until 6 months after the last dose of the investigational drug and to voluntarily practice effective contraception during this period;
• Aged 18 to 70 years (inclusive) at the time of signing informed consent, either male or female. For the elderly group, subjects must be aged 65 years or older (inclusive);
• Body mass index (BMI) between 18 and 32 kg/m² (inclusive);
• Subjects in the healthy group should be matched as closely as possible to those in the hepatic impairment, renal impairment, and elderly groups in terms of gender and weight, and additionally matched for age with the hepatic and renal impairment groups;
• Subjects in the hepatic impairment group must also meet all of the following additional criteria:
• Subjects with chronic liver injury due to primary liver diseases (e.g., hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.), classified as Child-Pugh Grade B hepatic insufficiency; Clinically diagnosed cirrhosis; eGFR \> 59 mL/min; Subjects are either those with a stable concomitant medication regimen (for hepatic impairment/complications/other diseases) for ≥2 weeks pre-dose not requiring anticipated adjustment (excluding, e.g., diuretics/insulin), or those not on such medications;
• Subjects in the renal impairment group must also meet all of the following additional criteria:
• Diagnosed with chronic kidney disease (CKD), defined as the presence of any marker of kidney damage or GFR \< 60 mL/min for more than 3 months (evidence may include outpatient records, inpatient records, or laboratory reports); GFR must meet the following criteria: Moderate renal impairment (CKD Stage 3): 30-59 mL/min (inclusive); Severe renal impairment (CKD Stage 4): 15-29 mL/min (inclusive); Note: Staging will be determined solely based on the second scheduled GFR measurement during the screening period; Renal function must be stable, defined as meeting either of the following criteria based on two GFR measurements taken prior to dosing (with at least a 3-day interval between measurements): Both results fall within the same CKD stage; or the fluctuation between the two GFR results is \<10% (calculated as: \[(Second result - First result) / First result\] × 100%).

You may not qualify if:

• Subjects with a history of hypersensitivity or allergic constitution (including severe drug allergies or drug hypersensitivity reactions), or with a known allergy to the investigational drug or any of its excipients;
• QTcF (male) \> 470 ms, QTcF (female) \> 480 ms;
• Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite antihypertensive therapy. This criterion does not apply to subjects in the healthy group;
• History of dysphagia or any gastrointestinal disorder that may affect drug absorption, including frequent nausea or vomiting due to any etiology;
• History of severe infection, trauma, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening;
• Receipt of any vaccine within 14 days prior to screening, or intention to receive any vaccination during the course of the study;
• Donation or loss of blood ≥ 400 mL within 3 months prior to screening, or intention to donate blood during the study;
• Use of moderate or strong CYP3A4 inhibitors/inducers within 2 weeks prior to screening, or planned concomitant use during the study; or use of CYP3A4-sensitive substrates within 2 weeks prior to screening or planned use during the study;
• Use of proton pump inhibitors (PPIs, e.g., rabeprazole, pantoprazole, esomeprazole) within 2 weeks prior to screening or planned concomitant use during the study; medications known to affect serum creatinine clearance (e.g., calcium dobesilate, trimethoprim/sulfamethoxazole, cimetidine); drugs prone to cause liver injury (e.g., non steroidal anti inflammatory drugs, antibiotics, antituberculosis agents, antifungals, glucocorticoids); or drugs with high plasma protein binding (e.g., warfarin, dicoumarol, diazepam, phenylbutazone, digitoxin);
• Consumption of special diets (including pitaya, mango, pomelo, and/or xanthine containing foods such as chocolate) within 2 weeks prior to dosing, and/or habitual excessive intake of tea, coffee, grapefruit/grapefruit juice, or caffeinated beverages (average \>8 cups per day, 200 mL per cup);
• History of excessive alcohol consumption, defined as \>14 units per week on average, within the 3 months preceding screening (where 1 alcohol unit equals 360 mL of beer, 45 mL of 40% distilled spirits, or 150 mL of wine);
• Positive result on alcohol breath test or urine drug screening at screening;
• Average cigarette consumption of ≥10 cigarettes per day within 3 months prior to screening;
• History of drug abuse or substance misuse;
• Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test;

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Conditions

Hepatic Insufficiency; Renal Insufficiency

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hong Zhang, PhD

  The First Bethune Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Zhang, PhD

CONTACT

+86-13654376192; jhongzhang@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 16, 2026
• Study Start: January 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

CN (1)