A Study of the Drug-Drug Interaction of RO5503781 and Posaconazole, the Relative Bioavailability of New Formulations of RO5503781 and the Food-Effect on the Pharmacokinetics of RO5503781 in Patients With Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Neoplasms
Interventions
DRUG

RO5503781

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

DRUG

RO5503781

Daily for 5 days followed by 23 days rest per cycle

DRUG

RO5503781

Single doses of current formulation, optimized MBP formulation and new SDP formulation, Days 1, 8 and 15 in a crossover design

DRUG

RO5503781

Single doses Days 1 and 11

DRUG

posaconazole

Multiple doses Days 8-14

Trial Locations (4)

75230

Dallas

85258

Scottsdale

M5G 2M9

Toronto

H3T 1E2

Montreal

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01901172 - A Study of the Drug-Drug Interaction of RO5503781 and Posaconazole, the Relative Bioavailability of New Formulations of RO5503781 and the Food-Effect on the Pharmacokinetics of RO5503781 in Patients With Solid Tumors | Biotech Hunter | Biotech Hunter