A Trial of SP2086 With Hepatic Insufficiency

NCT06035406 | Unknown Phase 1

• 1 other identifier: SP2086-117
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study used a single-dose, open design to compare the pharmacokinetics of subjects with mild and moderate liver impairment and subjects with normal liver function.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (3)

• PK parameters：Cmax；

  0hour to 72hours after the last dosing

• PK parameters：AUC0-t；

  0hour to 72hours after the last dosing

• PK parameters：AUC0-∞；

  0hour to 72hours after the last dosing

Secondary Outcomes (5)

• PK parameters：Tmax；

  0hour to 72hours after the last dosing

• PK parameters：t1/2；

  0hour to 72hours after the last dosing

• PK parameters：CL/F；

  0hour to 72hours after the last dosing

• PK parameters：V/F；

  0hour to 72hours after the last dosing

• Incidence and severity of adverse events (AEs)

  from screening to 168 hours after the last dosing

Study Arms (3)

Treatment group A: Retagliptin Phosphate Tablet

EXPERIMENTAL

Drug: Retagliptin Phosphate Tablet

Treatment group B: Retagliptin Phosphate Tablet

EXPERIMENTAL

Drug: Retagliptin Phosphate Tablet

Treatment group C: Retagliptin Phosphate Tablet

EXPERIMENTAL

Drug: Retagliptin Phosphate Tablet

Interventions

Retagliptin Phosphate Tablet DRUG

Retagliptin Phosphate Tablet;100mg

Treatment group A: Retagliptin Phosphate Tablet; Treatment group B: Retagliptin Phosphate Tablet; Treatment group C: Retagliptin Phosphate Tablet

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 informed consent before the test, and fully understand the test content, process and possible adverse reactions; And be able to complete the research according to the requirements of the test plan;
• The subjects (including their partners) are willing to voluntarily take effective contraceptive measures from screening until 2 weeks after the last study drug administration, as specified in Appendix 1;
• Age 18-70 years old (including the critical value), both male and female;
• The weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg. Body mass index (BMI) : 18-32 kg/m2 (including the cut-off value);
• (Only for subjects with normal liver function) The demographic mean of subjects in the normal liver function group (Group C) at screening must meet the following matching criteria:
• The body weight was matched with that of the liver function impairment group (group A + group B), with an average of ±10 kg;
• Age matching was performed with the liver function impairment group (group A + group B), and the mean was ±10 years old;
• Gender matching was performed with the liver function impairment group (group A + group B), with an average of ±1 cases;
• (Only for subjects with normal liver function) Normal or abnormal clinical laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function) have no clinical significance.
• (Only for subjects with normal liver function) No prior serious primary diseases of major organs, including but not limited to gastrointestinal, respiratory, kidney, liver, nervous, blood, endocrine, tumor, immune, psychiatric or cardiovascular and cerebrovascular diseases
• (Only for subjects with liver function impairment) Those who had not taken medication within 4 weeks prior to screening, or who had at least 4 weeks of stable medication for liver impairment and/or other comorbidification requiring long-term treatment
• (Only for subjects with liver function impairment) Patients with liver insufficiency due to previous primary liver disease with Child-Pugh grade A or B.

You may not qualify if:

• allergy, or known or suspected allergy to any of the ingredients in the investigational drug;
• Smoking an average of more than 10 cigarettes per day in the 3 months before screening;
• Alcoholics in the preceding 3 months, i.e. drinking more than 14 units of alcohol per week (1 unit = 285 mL for beer, 25 mL for spirits, or 100 ml for wine);
• Drug abusers or drug urine screening test positive;
• Blood donation or blood loss ≥400 mL within 3 months before screening, or receiving blood transfusion;
• Major surgery or surgical incision not fully healed within 6 months prior to screening;
• Had been exposed to DPP-IV inhibitors such as sitagliptin, saxagliptin, ligagliptin, vigagliptin within 1 month prior to administration;
• Chinese herbal medicine was taken within 2 weeks before administration;
• Have malignant tumors, or a history of malignant tumors within 5 years prior to screening (except for treated non-melanoma skin tumors with no signs of recurrence, and resected cervical intraepithelial neoplasia);
• Patients with a history of severe hypoglycemia;
• History of recurrent urinary tract infections or/and genital fungal infections;
• Those who are expected to have a tendency to undergo surgery or be hospitalized during the trial;
• Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg at the time of screening;
• Patients with clinically significant ECG abnormalities (such as tachycardia/bradycardia requiring medical treatment, degree II-III atrioventricular block, or QTcF (male) ≥470ms, QTcF (female) ≥480ms), or other clinically significant abnormalities determined by the investigator and judged by the investigator to be unsuitable for participation in this study;
• Female subjects were breastfeeding or had positive pregnancy results during the screening period or during the test;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sheng Feng

CONTACT

+86-0518-82342973; sheng.feng@hengrui.com

Xihan Wang

CONTACT

+86-0518-82342973; xihan.wang@hengrui.com

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: September 7, 2023
• First Posted: September 13, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09