This multicenter, open-label study will evaluate the effect of posaconazole on the pharmacokinetics of RO5503781, the relative bioavailability of two new RO5503781 formulations, and the effect of food on the pharmacokinetics of RO5503781 in patients with solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
61
Single dose on Day 1 (high fat, low fat, or fasted), Day 10 (fasted, low fat, or high fat), and Day 19 (low fat, fasted, or high fat) in a crossover design
Daily for 5 days followed by 23 days rest per cycle
Single doses of current formulation, optimized MBP formulation and new SDP formulation, Days 1, 8 and 15 in a crossover design
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
Toronto, Ontario, Canada
Unnamed facility
Montreal, Quebec, Canada
Part 1: Area under the concentration-time curve (AUC)
Time frame: 22 days
Part 1: Maximum concentration (Cmax)
Time frame: 22 days
Part 1: Change in serum macrophage inhibitory cytokine-1 (MIC-1)
Time frame: from baseline to Day 22
Part 2: Relative bioavailability: Area under the concentration-time curves (AUCs)
Time frame: 22 days
Part 3: Food effect: Area under the concentration-time curves (AUCs)
Time frame: 28 days
Safety: Incidence of adverse events in combination with posaconazole
Time frame: 28 days
Safety: Incidence of adverse events (new formulations)
Time frame: 28 days
Safety: Incidence of adverse events (optional treatment extension)
Time frame: approximately 1 year
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Single doses Days 1 and 11
Multiple doses Days 8-14