A MULTIPLE-CENTER, OPEN-LABEL CLINICAL PHARMACOLOGY STUDY WITH RO5503781, AN MDM2 ANTAGONIST, IN PATIENTS WITH SOLID TUMORS TO DETERMINE: PART 1 ONE-SEQUENCE, 2-PERIOD CROSSOVER DESIGN TO INVESTIGATE THE EFFECT OF POSACONAZOLE, A STRONG CYP3A4 INHIBITOR, ON THE PHARMACOKINETICS AND PHARMACODYNAMICS OF RO5503781 PART 2 A RANDOMIZED, SINGLE DOSE, 3 PERIOD CROSSOVER DESIGN TO INVESTIGATE THE RELATIVE BIOAVAILABILITY OF TWO NEW RO5503781 TABLET FORMULATIONS FOLLOWING ORAL ADMINISTRATION

Trial Profile

A MULTIPLE-CENTER, OPEN-LABEL CLINICAL PHARMACOLOGY STUDY WITH RO5503781, AN MDM2 ANTAGONIST, IN PATIENTS WITH SOLID TUMORS TO DETERMINE: PART 1 ONE-SEQUENCE, 2-PERIOD CROSSOVER DESIGN TO INVESTIGATE THE EFFECT OF POSACONAZOLE, A STRONG CYP3A4 INHIBITOR, ON THE PHARMACOKINETICS AND PHARMACODYNAMICS OF RO5503781 PART 2 A RANDOMIZED, SINGLE DOSE, 3 PERIOD CROSSOVER DESIGN TO INVESTIGATE THE RELATIVE BIOAVAILABILITY OF TWO NEW RO5503781 TABLET FORMULATIONS FOLLOWING ORAL ADMINISTRATION

Completed
Phase of Trial: Phase I

Latest Information Update: 05 Aug 2015

At a glance

  • Drugs Idasanutlin (Primary) ; Posaconazole
  • Indications Solid tumours
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Roche
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 11 May 2015 Status changed from active, no longer recruiting to completed, according to to ClinicalTrials.gov record.
    • 23 Feb 2015 Status changed from recruiting to active, no longer recruiting, according to ClinicalTrials.gov record.
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