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drugset / Trial / NCT01287091

A 3-Part Study to Determine the Relative Bioavailability of Capsule and Tablet Formulations of GDC-0980, the Effect of Food, and the Effect of Rabeprazole on the Pharmacokinetics of the Tablet

NCT01287091 ↗

Phase 1 Completed 46 enrolled Genentech, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This will be a single-center, open-label, 3 part study. The study is designed to determine the relative bioavailability of GDC-0980 capsule and tablet formulations under fasting conditions, the effects of a high-fat (fed) meal on the pharmacokinetics of the GDC-0980 tablet, and the effects of rabeprazole on the pharmacokinetics of the GDC-0980 tablet in the presence or absence of a high-fat meal.

Timeline

Start
2010-10-14
Primary completion
2011-02-03
Completion
2011-02-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Apitolisib Small molecule — Oral
Subject Rabeprazole Small molecule — Oral

Indications

No indication recorded.