An Open-label, Two-treatment Crossover Pharmacokinetic Interaction Study of Repeated Doses of SAR302503 on Pharmacokinetics of a Single Dose Cocktail of Omeprazole, Metoprolol, and Midazolam Used as Probe Substrates for CYP2C19, CYP2D6 and CYP3A4 Activities, Respectively in Adult Patients With Refractory Solid Tumors
The duration of the study for an individual patient will include a period to assess
eligibility (screening period 21 days), followed by a treatment period of at least 15 days
of study treatment, and an end-of-treatment visit at least 30 days following the last
administration of study drug. However, treatment may continue if patients are receiving
benefit and do not have unacceptable toxicity or meet study withdrawal criteria.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Omerprazole/metoprolol/midazolam - Pharmacokinetic parameter: AUC, AUClast
predose and up to 24 hours post dose on Days -1, 1, 15 and 16
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
INT12497
NCT01585623
June 2012
March 2013
Name | Location |
---|---|
Investigational Site Number 840001 | Detroit, Michigan 48201 |
Investigational Site Number 840002 | Philadelphia, Pennsylvania 19111 |
Investigational Site Number 840004 | Augusta, Georgia 30912 |