A Phase 1, Single-Dose, Randomized, Group Sequential Cross-Over Study Evaluating the Bioavailability and Food Effect of Three Formulations of Veliparib on Pharmacokinetics in Subjects With Solid Tumors
Interventional
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the oral bioavailability of veliparib
Assess the relative bioavailability of Formulation A, Formulation B and Formulation C with or without food measured using area under the plasma concentration-time curve (AUC), the maximum observed plasma concentration (Cmax), and time to Cmax (Tmax).
Up to 4 weeks.
No
Bhardwaj Desai, MD
Study Director
Abbott
United States: Food and Drug Administration
M11-846
NCT01199224
June 2010
November 2010
Name | Location |
---|---|
Site Ref # / Investigator 42142 | Encinitas, California 92024 |
Site Ref # / Investigator 41568 | Santa Monica, California 90404 |