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

NCT06883656 | Completed Phase 1

• 2 other identifiers: SAL067-C-011CTR20212745
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Renal Insuficiency

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

healthy subject

ACTIVE COMPARATOR

Matched healthy subjects

Drug: SAL067

Mild renal insufficiency

EXPERIMENTAL

Mild renal insufficiency was GFR by 60 to 89 mL/min.

Drug: SAL067

Moderate renal insufficiency

EXPERIMENTAL

Moderate renal insufficiency was GFR by 30 to 59 mL/min.

Drug: SAL067

Interventions

SAL067 DRUG

Fasting oral test drug 12mg

Mild renal insufficiency; Moderate renal insufficiency; healthy subject

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 (including 18 and 75 years old), both male and female;
• Weight: male ≥ 50 kg, female ≥ 45 kg; BMI in the range of 18 to 30 kg/m2 (including 18 and 30 kg/m2);
• During screening, the glomerular filtration rate (GFR) met the staging criteria of renal insufficiency or normal renal function in the corresponding group;
• 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.
• 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;
• 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;
• 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.

You may not qualify if:

• People who are known to be allergic to DPP-4 inhibitors or drug excipients in this study;
• Previous medication history:
• Use of DPP-4 enzyme inhibitors or similar within 2 weeks prior to screening;
• Inhibitors or inducers of the CYP 2D6 enzyme used within 30 days prior to screening or required during the trial;
• Vaccination within 4 weeks prior to screening;
• 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;
• Hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, HIV antigen antibody composite test any item is positive。

Sponsors & Collaborators

• Shenzhen Salubris Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, China, 61000, 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 19, 2025
• Study Start: March 15, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)