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The Effect of AST-120 on the Single-Dose Pharmacokinetics of Losartan and Losartan Acid (E-3174) in Healthy Subjects

From MDS Pharma Services, St-Laurent, Montreal, Canada (Dr Marier, Mr Guilbaud, S. R. P. Kambhampati); MDS Pharma Services, Clinical Research Center, Neptune, New Jersey (Dr Mathew); and Sankyo Pharma Development, Edison, New Jersey (Dr Moberly, Dr Lee, Dr Salazar).

AST-120 is an orally administered adsorbent used to slow the progression of chronic kidney disease (CKD). This was a randomized, open-label, 5-way crossover study to assess the effect of AST-120 on the pharmacokinetics of losartan and its active metabolite (E-3174) in healthy subjects. Losartan (100 mg) was administered alone under fasting (A) and fed (B) conditions, and results were compared when AST-120 (3 g thrice daily for 2 days) was administered 60 minutes after (C), 30 minutes prior to (D), and 30 minutes after (E) losartan. Plasma concentrations of losartan and E-3174 were assayed by high-performance liquid chromatography with mass spectrometry detection. Under fed conditions, treatment C had no significant effect on the AUC_(0-t) and C_max of losartan and E-3174. Treatments D and E resulted in a marked decrease in C_max of losartan and E-3174. Therefore, administration of AST-120 60 minutes after losartan under fed conditions may be preferred over other dosing regimens for CKD patients.

Key Words: AST-120 • oral adsorbent • losartan, drug interaction • pharmacokinetics

Address for reprints: Jean-Francois Marier, PhD, MDS Pharma Services, PK/PD, 2350 Cohen Street, St-Laurent (Montreal), Canada.

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