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An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin (P-gp); Sulfasalazine (BCRP); and the Cooperstown Cocktail (Midazolam [CYP3A4], Omeprazole [CYP2C19], Warfarin [CYP2C9], Caffeine [CYP1A2], and Dextromethorphan [CYP2D6]) in Healthy Subjects

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Trial Profile

An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin (P-gp); Sulfasalazine (BCRP); and the Cooperstown Cocktail (Midazolam [CYP3A4], Omeprazole [CYP2C19], Warfarin [CYP2C9], Caffeine [CYP1A2], and Dextromethorphan [CYP2D6]) in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Rolapitant (Primary) ; Caffeine; Dextromethorphan; Digoxin; Midazolam; Omeprazole; Sulfasalazine; Warfarin
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Pharmacokinetics
  • Sponsors TESARO

    • Most Recent Events

    • 25 Apr 2018 Results (n=36) published in the Journal of Clinical Pharmacology
    • 14 Sep 2017 Results of four open-label phase 1 studies evaluating the safety and drug-drug interactions of a single dose of rolapitant given intravenously (166.5 mg) or orally (180 mg) with oral digoxin (0.5 mg) or sulfasalazine (500 mg) published in the Journal of Clinical Pharmacology
    • 23 Jun 2016 Results from this trial were presented at the 2016 MASCC/ISOO Annual Meeting on Supportive Care, according to a Tesaro media release.
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