title: A phase 1 study to evaluate effect of food on veliparib pharmacokinetics and relative bioavailability in subjects with solid tumors.
abstract: OBJECTIVE
  A phase 1 study was conducted to evaluate the bioavailability and food effect of a new veliparib formulation in subjects with solid tumors.
  
  
  METHODS
  Subjects (planned: Stage I, N = 20; Stage II, N = 16) received four regimens of a single oral dose of veliparib utilizing a group-sequential design. Subjects were administered single doses of 40 mg veliparib supplied as four 10 mg current formulation, four 10 mg new formulation and one 40 mg new formulation under fasting conditions and under non-fasting conditions. Serial blood samples were collected for the determination of veliparib pharmacokinetics. At the end of Stage I, the relative bioavailability between each pair of regimens was assessed by a two one-sided tests procedure from the analyses of the natural logarithms of C(max) and AUC. A 92.7 % confidence interval within the 0.80-1.25 range between each regimen pair determined bioequivalence.
  
  
  RESULTS
  Four 10 mg current formulation capsules, four 10 mg new formulation and one 40 mg new formulation were bioequivalent with respect to C(max) and AUC under fasting conditions. The administration of a high-fat meal did not have a significant effect on AUC and only caused a slight decrease in veliparib C(max) (17 %) and a delay of approximately 1 h in T(max).
  
  
  CONCLUSIONS
  The 40 mg new capsule was bioequivalent to currently used formulation. Food had no effect on the extent of veliparib absorption and only a small (17 %) decrease in peak exposure of veliparib.
authors: Research and Development, AbbVie Inc., One N. Waukegan Road, North Chicago, IL, 60064, USA, nael.mostafa@abbvie.com.
authors: Nael M
authors: NM
authors: Mostafa
authors: Yi-Lin
authors: YL
authors: Chiu
authors: Lee S
authors: LS
authors: Rosen
authors: Alberto
authors: A
authors: Bessudo
authors: Xenia
authors: X
authors: Kovacs
authors: Vincent L
authors: VL
authors: Giranda
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000493:pharmacokinetics; D019540:Area Under Curve; D001562:Benzimidazoles / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001682:Biological Availability; D002214:Capsules; D004032:Diet; D005215:Fasting; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D013810:Therapeutic Equivalency
chemical_list: D000970:Antineoplastic Agents; D001562:Benzimidazoles; D002214:Capsules; C521013:veliparib