Solid Tumours Clinical Trial
Official title:
An Open-Label, Randomised, Two Part, Two Treatment Crossover Study in Healthy Subjects to Assess the Pharmacokinetics of Savolitinib When Administered Alone and in Combination With Famotidine
This will be an open-label, randomised, 2 part (Part A and Part B), 2 treatment (savolitinib alone or in combination with famotidine), crossover study in healthy, non Japanese, male subjects, performed at a single study centre.
Parts A and B will each have 2 Periods (Period 1 and Period 2) with a crossover design. Part
B will be conducted only if results of Part A suggest a clinically meaningful effect of
famotidine on savolitinib pharmacokinetics (PK) parameters. In both parts subjects will be
randomly assigned 1:1 to receive one of the 2 treatment sequences: savolitinib alone first
followed by crossover to the combination treatment of savolitinib+famotidine, or the reverse
sequence. Subjects will be admitted for 4 days from one day before the first dose of the
study drug and discharged 2 days after. There will be a washout period (no study treatment)
of 14 days between the 2 Periods. The essential difference between the 2 parts is that in the
combination treatment, famotidine will be administered 2 hours before savolitinib in Part A
and 6 hours before savolitinib in Part B. A given subject will receive a total of 1 dose of
famotidine and 2 doses of savolitinib during the study.
In this 2 part study, 16 subjects will be randomised in each part to ensure at least 14
evaluable subjects at the end of the last study period. If Part B is conducted, a total of 32
subjects overall are planned to be enrolled in the study. Additional subjects may be enrolled
to ensure 14 evaluable subjects in each part if more than 2 subjects are deemed non
evaluable.
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