The Pharmacokinetics Study of Fotagliptin in Patients with Different Degrees of Renal Insufficiency (RI)

The Pharmacokinetics Study of Fotagliptin in Patients with Different Degrees of Renal Insufficiency and Matched Healthy Volunteers with Normal Renal Function

The trial was designed in a single dose, open, non-randomized, multi-dose parallel control group. The study of patients were mild and moderate renal insufficiency, and matched healthy subjects.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus (T2DM); Renal Insuficiency
• Intervention / Treatment: Drug: SAL067

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Chengdu, China, 61000
    • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 18 to 75 (including 18 and 75 years old), both male and female;
2. Weight: male ≥ 50 kg, female ≥ 45 kg; BMI in the range of 18 to 30 kg/m2 (including 18 and 30 kg/m2);
3. During screening, the glomerular filtration rate (GFR) met the staging criteria of renal insufficiency or normal renal function in the corresponding group;
4. The subjects can communicate well with the researchers, fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign a written informed consent.
5. During screening, the investigators judged that the kidney disease of the subjects was stable from 4 weeks before screening to the end of the study, and GFR did not change significantly;
6. Patients who had not taken or were on stable medication for renal insufficiency and/or other comorbiditions during the 4 weeks prior to screening and agreed to continue treatment during the study period;
7. Patients with diabetes who have not used hypoglycemic drugs in the 4 weeks prior to screening, or who are receiving stable antidiabetic therapy (including lifestyle interventions, use of stable doses of drugs, except for prohibited drugs described in the trial protocol) and agree to continue treatment during the study period.

Exclusion Criteria:

1. People who are known to be allergic to DPP-4 inhibitors or drug excipients in this study;

2. Previous medication history:

   1. Use of DPP-4 enzyme inhibitors or similar within 2 weeks prior to screening;
   2. Inhibitors or inducers of the CYP 2D6 enzyme used within 30 days prior to screening or required during the trial;
3. Vaccination within 4 weeks prior to screening;
4. Pregnant or lactating women; The subject and his or her spouse or partner have plans to become pregnant, or plan to donate sperm or eggs, or do not agree to an acceptable and effective method of contraception within 3 months of dosing;
5. Hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, HIV antigen antibody composite test any item is positive。

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: healthy subject; Matched healthy subjects	Drug: SAL067; Fasting oral test drug 12mg
Experimental: Mild renal insufficiency; Mild renal insufficiency was GFR by 60 to 89 mL/min.	Drug: SAL067; Fasting oral test drug 12mg
Experimental: Moderate renal insufficiency; Moderate renal insufficiency was GFR by 30 to 59 mL/min.	Drug: SAL067; Fasting oral test drug 12mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic characteristics	Peak blood concentration (Cmax)	8 day
Pharmacokinetic characteristics	Area under the curve from 0 to the last time point t (AUC0-last)	8 day
Pharmacokinetic characteristics	Area under the curve from 0 to infinity (AUC0-inf)	8 day

Collaborators and Investigators

• Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 2; Renal Insufficiency
• Other Study ID Numbers: SAL067-C-011; CTR20212745 (Other Identifier: NMPA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No