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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Savolitinib (Primary) ; Midazolam
  • Indications CNS cancer; Colorectal cancer; Gastric cancer; Non-small cell lung cancer; Oesophageal cancer; Prostate cancer; Renal cell carcinoma; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors AstraZeneca

Most Recent Events

  • 28 Jul 2021 Results assessing the effect of rifampicin, itraconazole and famotidine on savolitinib PK, and the effect of savolitinib on midazolam exposure from four studies (NCT04118842, NCT04121910, NCT04179071,NCT04187456) published in the British Journal of Clinical Pharmacology
  • 21 Apr 2021 Results of two open label studies (NCT04187456 and NCT04179071), presented at the 122nd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics and International Transporter Consortium Workshop 4
  • 26 Mar 2020 Status changed from recruiting to completed.

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