Clinical trial NCT06883656: The Pharmacokinetics Study of Fotagliptin in Patients with Different Degrees of Renal Insufficiency
Official title: The Pharmacokinetics Study of Fotagliptin in Patients with Different Degrees of Renal Insufficiency and Matched Healthy Volunteers with Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus (T2DM)
Renal Insuficiency
Lead sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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。

Primary outcomes:
measure: Pharmacokinetic characteristics
timeFrame: 8 day
measure: Pharmacokinetic characteristics
timeFrame: 8 day
measure: Pharmacokinetic characteristics
timeFrame: 8 day
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
Study officials:
References: