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Phase I, Open-label, Single-sequence, Cross-over Study of the Effect of Multiple Doses of Itraconazole on Single-dose Tepotinib Pharmacokinetics in Healthy Participants

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Trial Profile

Phase I, Open-label, Single-sequence, Cross-over Study of the Effect of Multiple Doses of Itraconazole on Single-dose Tepotinib Pharmacokinetics in Healthy Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Feb 2024

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At a glance

  • Drugs Itraconazole (Primary) ; Tepotinib (Primary)
  • Indications Colorectal cancer; Liver cancer; Non-small cell lung cancer; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Merck KGaA

Most Recent Events

  • 24 Mar 2023 Results assessing the impact of the strong CYP3A4 inhibitor and P-gp inhibitor itraconazole (200 mg QD as capsules, N=18, NCT05203822), and of the CYP/P-gp inducer carbamazepine (titrated up to 300 mg BID, N=18, NCT05213481) on the pharmacokinetics of single 450 mg doses of tepotinib, presented at the 124th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
  • 26 Jul 2022 Status changed from active, no longer recruiting to completed.
  • 05 Jun 2022 Planned End Date changed from 13 May 2022 to 29 Jun 2022.

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