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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus (T2DM); Renal Insuficiency
• Interventions: Drug: SAL067

• Registration Number: NCT06883656
• Lead Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-15
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy subject	SAL067	Matched healthy subjects
Mild renal insufficiency	SAL067	Mild renal insufficiency was GFR by 60 to 89 mL/min.
Moderate renal insufficiency	SAL067	Moderate renal insufficiency was GFR by 30 to 59 mL/min.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic characteristics	8 day	Area under the curve from 0 to infinity (AUC0-inf)

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, China