Effect of Food Intake or Coadministration With an Acid-Reducing Agent on Lenacap...

연구 요약

Effect of Food Intake or Coadministration With an Acid-Reducing Agent on Lenacapavir Pharmacokinetics Following Oral Administration.

Clinical pharmacology in drug development 학술지에 발표된 이 연구는 Singh R, Shelton M, Olson I 외 연구팀이 수행하였습니다.

이 연구는 'Effect of Food Intake or Coadministration With an Acid-Reducing Agent on Lenacapavir Pharmacokinetics Following Oral Administration.'에 대한 과학적 분석을 제공합니다.

핵심 내용

Lenacapavir is a potent, long-acting HIV-1 capsid inhibitor used in combination with other antiretrovirals to treat HIV-1 infection. The pharmacokinetics of orally administered drugs may be affected by food intake or coadministration of acid-reducing agents (ARA). Two Phase 1 studies were conducted on healthy participants to evaluate the effect of food and the impact of the histamine H2-receptor antagonist famotidine in parallel cohorts. In Study 1, oral lenacapavir (300 mg) was administered under fasting conditions, after a standardized high-fat meal, and after a low-fat meal (n = 8/cohort). In Study 2, lenacapavir 300 mg was administered alone (n = 27) and 2 hours after famotidine (40 mg; n = 25), each under fasting conditions. For the high-fat meal versus fasted comparison, the percentage geometric least-squares mean (%GLSM) ratios for the lenacapavir area under the curve to infinity (AUCinf) and maximum concentration (Cmax) were 115.2 and 145.2, respectively. For the low-fat meal, the %GLSM ratios for lenacapavir AUCinf and Cmax were 98.6 and 115.8, respectively, versus the fasted state. In the famotidine study, the %GLSM ratio for lenacapavir AUC from time zero to the last quantifiable concentration was 137.4, and for Cmax was 100.6. Based on available clinical safety data, the exposure increases observed in these studies were not expected to be clinically relevant. Overall, these data support the dosing of oral lenacapavir without regard to food intake or coadministration with ARAs.

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