Effect of Food on the Pharmacokinetics of Senaparib (IMP4297) in Healthy Chinese Subjects.

ABSTRACT:

Background and objectives

Data on the effect of food on the pharmacokinetics of senaparib (previously IMP4297), an oral poly (adenosine diphosphate-ribose) polymerase inhibitor, are limited. This study was conducted to evaluate the effect of food on the pharmacokinetics of senaparib in healthy Chinese subjects.

Methods

This is a phase I, open-label, randomized, single-dose, two-way crossover study. Healthy Chinese male subjects were randomized 1:1 to receive a single dose of senaparib 100 mg in two prandial states: fasted or after a high-fat meal; subjects were given a second dose after switching prandial states and a washout period of at least 7 days. Pharmacokinetics were assessed at pre-dose and up to 72 h post-dose. Safety was assessed throughout the study.

Results

SUBMITTER: Meng X 

PROVIDER: S-EPMC9617823 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature