Evaluation of Food Effect on Pharmacokinetics of Vismodegib
Summary
This randomized clinical trial studies the effect of food on the pharmacokinetics of vismodegib. Studying the effects of meals on the absorption of vismodegib may help doctors prescribe correct doses and label the drug accurately.
Timeline
- Start
- 2009-10
- Primary completion
- 2014-12
- Completion
- 2014-12
Outcome
Mixed primary results
registry Arm I (Vismodegib on Empty Stomach) vs Arm II (Vismodegib After High Fat Meal); p = 0.003; Ratio of geometric means 1.75 (90% CI 1.30 to 2.34) NCT01174264 ↗
registry Arm I (Vismodegib on Empty Stomach) vs Arm II (Vismodegib After High Fat Meal); p = 0.008; Ratio of geometric means 1.74 (90% CI 1.25 to 2.42) NCT01174264 ↗
registry Arm I (Vismodegib on Empty Stomach) vs Arm III (Vismodegib After Low Fat Meal); p = 0.65; Ratio of geometric means 1.08 (90% CI 0.81 to 1.44) NCT01174264 ↗
registry Arm I (Vismodegib on Empty Stomach) vs Arm III (Vismodegib After Low Fat Meal); p = 0.51; Ratio of geometric means 1.12 (90% CI 0.84 to 1.49) NCT01174264 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vismodegib | Small molecule | — | Oral |