drugset / Trial / NCT01980953
A Study to Evaluate the Effect of Particle Size, Formulation and Food on the Pharmacokinetics of GDC-0032 in Healthy Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Taselisib | Small molecule | 2 mg | Oral |
| Subject | Taselisib | Small molecule | 3 mg | Oral |
Indications
No indication recorded.