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Pharmacokinetics of Atorvastatin and Metformin after Coadministration with Islatravir in Healthy Adults

阿托伐他汀 二甲双胍 医学 药代动力学 药理学 血脂异常 药物相互作用 口服 内科学 糖尿病 内分泌学
作者
Jacqueline B. McCrea,Munjal Patel,Yang Liu,Ryan Vargo,Rose Witter,Andrew Litovsky,S. Aubrey Stoch,Marian Iwamoto,Randolph P. Matthews
出处
期刊:The Journal of Clinical Pharmacology [Wiley]
标识
DOI:10.1002/jcph.6169
摘要

Abstract Islatravir, a deoxyadenosine analog that inhibits HIV‐1 replication by multiple mechanisms of action, including reverse transcriptase translocation inhibition, is being developed for use in HIV‐1 treatment. People living with HIV often have comorbidities, such as dyslipidemia or type 2 diabetes mellitus, necessitating long‐term concomitant drug therapy. This nonrandomized, two‐period, fixed‐sequence, open‐label, phase 1, drug‐drug interaction study was conducted to evaluate the effects of islatravir coadministration on atorvastatin and metformin pharmacokinetics (PK) in healthy adults. In period 1, participants received a single dose of atorvastatin 20 mg and metformin 1000 mg. After a 5‐day washout, participants received atorvastatin 20 mg and metformin 1000 mg coadministered with a single oral dose of islatravir 60 mg (period 2). In both periods, blood samples were collected up to 72 h post dose to characterize the plasma PK of atorvastatin and metformin. Safety was monitored throughout the study. Fourteen participants were enrolled and completed the study. Atorvastatin and metformin plasma PK were similar after administration of atorvastatin and metformin with or without islatravir. The geometric mean ratio and 90% confidence interval of the area under the concentration‐time curve from time zero to infinity (AUC 0‐∞ ) for atorvastatin and metformin with or without a single oral dose of islatravir were 1.04 (1.00‐1.10) and 0.87 (0.79‐0.96), respectively. Coadministration of islatravir with atorvastatin and metformin was well tolerated. Overall, coadministration of atorvastatin and metformin with a single oral dose of islatravir did not have a clinically meaningful effect on the PK profiles of either drug.

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