Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

  • STATUS
    Not Recruiting
  • End date
    Jan 9, 2023
  • participants needed
    42
  • sponsor
    Pfizer
Updated on 20 July 2022

Summary

This is an open-label, 3-arm, fixed-sequence study to evaluate the effect of single and multiple oral doses of encorafenib in combination with binimetinib on the single oral dose pharmacokinetics (PK) of cytochrome P450 (CYP) enzyme probe substrates using a probe cocktail, on an organic anion-transporting polypeptide/breast cancer resistance protein (OATP/BCRP) substrate using rosuvastatin and on a CYP2B6 substrate using bupropion. The effect of multiple oral doses of the moderate cytochrome P450 (CYP) inhibitor modafinil on encorafenib in combination with binimetinib will also be assessed. The study will have 2 treatment phases, a drug-drug interaction (DDI) phase followed by a post-DDI phase.

Details
Condition Advanced Solid Tumors, Metastatic Melanoma
Treatment Modafinil, Midazolam, dextromethorphan, Rosuvastatin, caffeine, losartan, Omeprazole, Binimetinib, Encorafenib, bupropion immediate release (IR)
Clinical Study IdentifierNCT03864042
SponsorPfizer
Last Modified on20 July 2022

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