A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Pyroglutamate Rongliflozin Capsules in Subjects With Mild and Moderate Liver Damage

NCT05427682 | Completed Phase 1

• 1 other identifier: DJT1116PG-DM-105
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in subjects with mild and moderate liver damage and healthy subjects

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum plasma concentration of study drugs

  0 hour（pre-dose） to 96 hours after administration

• AUC

  Maximum plasma concentration of study drugs

  0 hour（pre-dose） to 96 hours after administration

• Adverse Events

  Incidence of adverse events

  Day -1 (Baseline) to Day 5

Study Arms (4)

Group A (normal liver function)

EXPERIMENTAL

Each subject will receive a single dose of rongliflozin on Day 1

Drug: pyroglutamate rongliflozin capsules

Group B (mild liver damage)

EXPERIMENTAL

Each subject will receive a single dose of rongliflozin on Day 1

Drug: pyroglutamate rongliflozin capsules

Group C (normal liver function)

EXPERIMENTAL

Each subject will receive a single dose of rongliflozin on Day 1

Drug: pyroglutamate rongliflozin capsules

Group D (moderate liver damage)

EXPERIMENTAL

Each subject will receive a single dose of rongliflozin on Day 1

Drug: pyroglutamate rongliflozin capsules

Interventions

pyroglutamate rongliflozin capsules DRUG

Subjects will receive one 50mg capsule on Day 1

Group A (normal liver function); Group B (mild liver damage); Group C (normal liver function); Group D (moderate liver damage)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form before the experiment, understand and abide by the research process, and participate voluntarily;
• Adult subjects between the ages of 18 and 70 (including boundary values), both male and female;
• Female subjects or male subjects with potential fertility must agree to use effective contraceptive methods (see Appendix 2 for specific contraceptive methods) from signing informed consent to taking the trial drug within 4 weeks to avoid pregnancy or make their partners pregnant.
• The following selection criteria are only applicable to healthy subjects with normal liver function (groups A and C): the gender and age (+ or - 5 years) of subjects in groups A and C are matched with subjects in groups B and D respectively;
• The following selection criteria are only applicable to healthy subjects with normal liver function (groups A and C): body mass index (BMI): 18-30kg/m2 (including cut-off value) \[BMI=weight (kg)/height 2 (m2) )\] (BMI matching between groups A and C and groups B and D is + or - 15%);
• The following selection criteria are only applicable to healthy subjects with normal liver function (groups A and C): medical history, physical examination, vital signs monitoring, electrocardiogram, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation) Function), alpha-fetoprotein (AFP), abdominal B-ultrasound (liver, spleen, gallbladder, pancreas, kidneys), and chest radiographs have normal or abnormal results, but the investigator judges them to be of no clinical significance.
• The following selection criteria are only applicable to subjects with liver dysfunction (groups B and D): for subjects with liver dysfunction without ascites, subclinical ascites, clinically mild and moderate ascites detected only by ultrasound or other imaging , Allow the body mass index (BMI) to be between 18-30 kg/m2 (including the critical value) \[BMI= weight (kg) / height 2 (m2)\];
• The following selection criteria are only applicable to subjects with liver dysfunction (groups B and D): according to the Child-Pugh classification (see Appendix 3) at the time of screening to evaluate the severity of patients with liver dysfunction in accordance with: (Grade A/Mild: Child -Pugh score 5 or 6 points; B grade/moderate: Child Pugh score 7-9 points);
• The following selection criteria are only applicable to subjects with liver dysfunction (groups B and D): combined with previous medical history, physical examination results, serological indicators (such as albumin, ALT, AST, bilirubin, prothrombin time, INR, etc.) ) And one of the following tests performed with standard diagnostic and treatment methods that meets the diagnostic basis for chronic liver disease: liver biopsy, computed tomography, magnetic resonance imaging, ultrasound, radioactive liver/spleen scan, laparoscopy;
• The following selection criteria are only applicable to subjects with liver damage (groups B and D): within 1 month before taking the test drug or 5 half-lives of the concomitant drug (whichever is longer) to the end of the study Those who have stable medication regimens for the treatment of liver dysfunction, liver disease complications and other concomitant diseases without adjustment (including the type of medication, dosage, or frequency of medication) or those who have not taken medication before enrollment; however, the study doctor's judgment does not affect Except for the adjustment of subject safety and pharmacokinetic endpoints;
• The following selection criteria are only applicable to subjects with liver dysfunction (groups B and D): the investigator judges that the liver function status of the subjects is stable and will not deteriorate significantly during the period from 1 month before taking the test drug to the end of the study By.

You may not qualify if:

• The subject has a history of severe allergies or allergies to the test drug and any of its components or related excipients;
• People with history of gastrointestinal or kidney disease or surgery (except for uncomplicated appendicitis resection and hernia repair) that may potentially affect the absorption, distribution, metabolism, and excretion of the test drug in the 6 months prior to screening, or the presence can make compliance People with reduced disease;
• The researcher judged that he currently has bleeding disorders, such as gastric and duodenal ulcers;
• People with a history of liver cancer or other malignant tumors before signing the informed consent form \[exceptions: specific cancers (basal cell carcinoma of the skin, squamous cell carcinoma, or cervical carcinoma in situ, etc.) that are surgically removed and completely cured can be selected\] or are currently assessed for existence People with potential malignant tumors;
• Patients with a history of repeated urinary tract infections or/and genital infections within 6 months before screening (recurrent urinary tract infection is defined as: repeated urinary tract infections \> or = 2 times within 6 months, or repeated urinary tract infections in the past 12 months Infection \> or =3 times);
• People with a history of recurring severe unconscious hypoglycemia (repeated severe hypoglycemia is defined as: 2 severe neurological symptoms in 4 weeks, hypoglycemia requiring the assistance of others to treat, or 2 blood glucose in 4 weeks\< 3.0 mmol/L, or blood glucose \< or = 3.9 mmol/L \> or =3 times detected within 1 week);
• People with a history of alcoholism (alcoholism is defined as: drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine) or those who have a positive alcohol breath test during the screening period;
• Those who have a history of drug abuse or have used drugs within 2 years before screening or those who have a positive urine drug screening during the screening period;
• Those who smoked more than 5 cigarettes a day in the 3 months before screening or who could not give up smoking from signing informed consent to leaving the group;
• Treponema pallidum antibody and/or human immunodeficiency virus (HIV) antibody test results are positive;
• Have taken food or drinks that affect CYP3A4 metabolic enzymes, such as grapefruit or drinks containing grapefruit within 7 days before the first medication;
• Consume chocolate, any food or drink that contains caffeine or is rich in xanthine within 72 hours before the first medication;
• Have taken any alcohol-containing products within 48 hours before the first medication;
• Those who donated blood \> or = 400 mL or a large amount of blood loss within 3 months before screening, or who have a history of blood transfusion within 1 month before screening, or who plan to donate blood within 1 month after the end of the test;
• Have taken similar SGLT-2 inhibitor drugs within 14 days before screening or participated in other clinical trials within 3 months before screening (if the subject withdrew from the study before treatment, that is, not randomized or received treatment, they can be included in the group Research);

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

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

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 22, 2022
• Study Start: April 19, 2022
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: May 5, 2026

Record last verified: 2022-06

Locations

CN (1)