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
Phase of Trial: Phase I
Latest Information Update: 14 Sep 2017
At a glance
- Drugs Rolapitant (Primary)
- Indications Chemotherapy-induced nausea and vomiting
- Focus Pharmacokinetics
- Sponsors TESARO
- 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.
- 24 Aug 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.