drugset / Trial / NCT01980953

A Study to Evaluate the Effect of Particle Size, Formulation and Food on the Pharmacokinetics of GDC-0032 in Healthy Volunteers

NCT01980953

Phase 1 Completed 76 enrolled Genentech, Inc.
RandomizedCrossoverOpen-labelOther

Summary

This 4-part study will assess the effect of formulation, food, and active pharmaceutical ingredient (API) lot on the pharmacokinetics of GDC-0032 in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study, and Parts 2, 3, and 4 are open-label 2-period crossover studies. Participants will receive single doses of GDC-0032 capsule or tablet formulation, in the fasted or fed state.

Timeline

Start
2013-11
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Taselisib Small molecule 2 mg Oral
Subject Taselisib Small molecule 3 mg Oral

Indications

No indication recorded.