An open label, 2 period, fixed-sequence study to assess the effect of savolitinib on the pharmacokinetics of oral midazolam (a CYP450 3A probe) in healthy subjects
18 Years - 65 Years
Endpoint Classification: -
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Verified 01 Sept 2020 by AstraZeneca
No locations available
|Experimental: Midazolam + Savolitinib|
• Treatment Period 1: Single administration of midazolam (1 mg) will occur on Study Day 1, after a high fat, high calorie breakfast, followed by PK sampling for 24 hours. • Treatment Period 2: Single administration of midazolam 1 mg in combination with a single administration of savolitinib (600 mg), after a high fat, high calorie breakfast will occur on Study Day 5 and PK sampling will occur for 24 hours.
Single dose (together with midazolam) on Study Day 5 after a high fat, high calorie breakfast.
Single dose (alone) on Study Day 1 and single dose (together with savolitinib) on Study Day 5, both after a high fat, high calorie breakfast.