Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/3/2016 |
| Start Date: | October 2015 |
| End Date: | November 2015 |
A Phase 1, Single-Dose, Randomized, Cross-Over, Relative Bioavailability, and Food Effect Study of Ipatasertib (GDC-0068) in Healthy Subjects
This Phase I, open-label, randomized, 3-period crossover study was designed to determine the
relative bioavailability of ipatasertib administered as capsule and tablet formulations to
healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be
determined. Participants will be randomized to one of six treatment sequences to receive
three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in
the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the
fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations
will be performed throughout the study. Time on study is expected to be 3 weeks.
relative bioavailability of ipatasertib administered as capsule and tablet formulations to
healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be
determined. Participants will be randomized to one of six treatment sequences to receive
three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in
the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the
fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations
will be performed throughout the study. Time on study is expected to be 3 weeks.
Inclusion Criteria:
- Healthy males or females, between 18 and 55 years of age, inclusive
- Body mass index between 18.5 and 29.9 kg/m^2, inclusive
Exclusion Criteria:
- Clinically significant findings from medical history or screening evaluations.
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