PK and PD of YG1699 in CKD Patients With Diabetes
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRenJi Hospital
About this trial
The goal of this clinical trial is to learn PK and PD of YG1699 in patients with diabetes and renal dysfuction.
Participants will:
Take YG1699 or a placebo every day for 8 days. Visit the clinic 7 times for checkups and tests. Keep a diary of their symptoms. Estimate PK data from a single dose of YG1699. Estimate PD data at baseline and the last day.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to provide informed consent
Male or female patients ,age between 18 and 70 at screening
Meet the diagnostic criteria for diabetic nephropathy, including patients with type 1 or type 2 diabetes;
Fasting blood glucose <11.1 mmol/L, stable on baseline anti-diabetic medication
Disqualifiers
Hypoglycemia occurs more than 2 times in one month
History of ketoacidosis
Patients who are being treated with swiram and digoxin
Patients with acute kidney injury (serum creatinine increased by ≥ 50% within 1 week)
Trial design
Design model
Parallel
Treatments tested in this trial
YG1699
Drug10mg qd for 8 days
Placebo
Drug10mg qd for 8 days
Treatment groups
20 Participants
are divided into 4 treatment groupsGroup A: eGFR≥30+YG1699Experimental treatment 1 intervention
Group B: Hemodialysis+YG1699Experimental treatment 1 intervention
Group C: eGFR<20+YG1699Experimental treatment 1 intervention
Group D: eGFR<20+placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
YG1699 concentration in plasma at different time
single-dose pharmacokinetic
Time frame
0 hour (h), 0.5h, 1h, 2h, 4h, 8h and 12h after the first dose of YG1699 (Day1); 24 hours after the first dose of YG1699 (Day2 morning)Secondary outcomes
1
Metabolite 1 concentration in plasma at different time
single-dose pharmacokinetic
Time frame
0 hour (h), 0.5h, 1h, 2h, 4h, 8h and 12h after the first dose of YG1699 (Day1); 24 hours after the first dose of YG1699 (Day2 morning)2
YG1699 steady-state concentration in plasma
steady-state pharmacokinetic
Time frame
Day 9 morning（the first day after discontinuation of the drug）3
Metabolite 1 steady-state concentration in plasma
steady-state pharmacokinetic
Time frame
Day 9 morning（the first day after discontinuation of the drug）4
Hemodialysis clearance of YG1699
pharmacokinetic
Time frame
immediately before and immediately after the hemodialysis treatment on Day9Other outcomes
1
Red blood cell count
Time frame
Day9 morning（the first day after discontinuation of the drug）2
White blood cell count
Time frame
Day 9 morning（the first day after discontinuation of the drug）3
Platelet count
Time frame
Day 9 morning（the first day after discontinuation of the drug）4
Hemoglobin
Time frame
Day 9 morning（the first day after discontinuation of the drug）Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: