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Polyethylene glycol loxenatide (PEX168) in subjects with renal impairment: A pharmacokinetic study.
British Journal of Clinical Pharmacology 2019 August 9
AIMS: Type 2 diabetes mellitus (T2DM) is commonly complicated by renal impairment. Polyethylene glycol loxenatide (PEX168) is a novel long-acting glucagon-like peptide-1 receptor agonist for T2DM. PEX168 pharmacokinetics (PK) was studied to identify requirements for dose-modification in T2DM complicated by renal impairment.
METHODS: This was a single-center, open-labeled, parallel-group, single-dose, phase I clinical trial of patients with mild and moderate renal impairment, and with or without T2DM. Age-, sex-, and body mass index (BMI)-matched subjects with normal renal function, and with or without T2DM were recruited as controls. Subjects received a single abdominal subcutaneous injection of PEX168 200 μg. Pharmacokinetic samples were taken at 0, 24, 48, 72, 96, 120, 144, 216, 312, 480, 648, and 720 h.
RESULTS: Twenty-three patients were included in the pharmacokinetics analysis. Vz/F and CL/F were lower in the moderate impairment group than in the other groups. The mean t1/2 (163 h) in the moderate impairment group was prolonged compared to the mild impairment (117 h) and normal (121 h) groups. AUC0-inf increased by 13% and 100.7% in patients with mild and moderate renal impairment. Most adverse events were mild gastrointestinal disorders, with only one serious adverse event observed.
CONCLUSION: A single dose of 200 μg of PEX168 was in general well tolerated in patients with renal impairment. The in vivo clearance rate of PEX168 in patients with moderate renal impairment is slower than in patients with mild renal impairment and normal renal function and dose adjustment might be required (ClinicalTrials.org #NCT02467790).
METHODS: This was a single-center, open-labeled, parallel-group, single-dose, phase I clinical trial of patients with mild and moderate renal impairment, and with or without T2DM. Age-, sex-, and body mass index (BMI)-matched subjects with normal renal function, and with or without T2DM were recruited as controls. Subjects received a single abdominal subcutaneous injection of PEX168 200 μg. Pharmacokinetic samples were taken at 0, 24, 48, 72, 96, 120, 144, 216, 312, 480, 648, and 720 h.
RESULTS: Twenty-three patients were included in the pharmacokinetics analysis. Vz/F and CL/F were lower in the moderate impairment group than in the other groups. The mean t1/2 (163 h) in the moderate impairment group was prolonged compared to the mild impairment (117 h) and normal (121 h) groups. AUC0-inf increased by 13% and 100.7% in patients with mild and moderate renal impairment. Most adverse events were mild gastrointestinal disorders, with only one serious adverse event observed.
CONCLUSION: A single dose of 200 μg of PEX168 was in general well tolerated in patients with renal impairment. The in vivo clearance rate of PEX168 in patients with moderate renal impairment is slower than in patients with mild renal impairment and normal renal function and dose adjustment might be required (ClinicalTrials.org #NCT02467790).
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