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A Phase 1, Open-Label, Fixed-sequence, 5-part, Drug-drug Interaction Study of Tucatinib to Evaluate the Effects of CYP3A4 and CYP2C8 Inhibition and Induction on the Pharmacokinetics of Tucatinib and to Evaluate the Effects of Tucatinib on the Pharmacokinetics of Substrates of CYP3A4, CYP2C8, CYP2C9, and P-glycoprotein in Healthy Male and Female Subjects

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Trial Profile

A Phase 1, Open-Label, Fixed-sequence, 5-part, Drug-drug Interaction Study of Tucatinib to Evaluate the Effects of CYP3A4 and CYP2C8 Inhibition and Induction on the Pharmacokinetics of Tucatinib and to Evaluate the Effects of Tucatinib on the Pharmacokinetics of Substrates of CYP3A4, CYP2C8, CYP2C9, and P-glycoprotein in Healthy Male and Female Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Aug 2022

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At a glance

  • Drugs Tucatinib (Primary) ; Digoxin; Gemfibrozil; Itraconazole; Midazolam; Repaglinide; Rifampicin; Tolbutamide
  • Indications Biliary cancer; Bladder cancer; Breast cancer; Cervical cancer; Cholangiocarcinoma; Colorectal cancer; Endometrial cancer; Gallbladder cancer; Gastric cancer; Gastrointestinal cancer; Non-small cell lung cancer; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Seagen

    • Most Recent Events

    • 06 Aug 2022 Results published in the Clinical Pharmacokinetics
    • 24 Jun 2020 Results presented at the 111th Annual Meeting of the American Association for Cancer Research - II
    • 14 Jan 2019 Status changed from recruiting to completed.
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