Healthy Volunteer
Conditions
Brief summary
This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the relative bioavailability of GDC-0941 administered as a single dose of the market image formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the Phase 2 formulation to healthy male and female volunteers. Participants will be randomly assigned to 4 possible treatment sequences, each comprising 4 periods (1 per formulation), and GDC-0941 will be administered based on the assigned sequence. The study is expected to last 8 weeks.
Interventions
DRUGGDC-0941
Single dose market image tablet of hardness 1
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female participants between 18 and 55 years of age, inclusive, * Body mass index (BMI) between 18.5 to 32 kg/m2, inclusive, * Healthy, as determined by no clinically significant findings from medical history, ECG, and vital signs, and who are able to swallow and tolerate a tethered Heidelberg pH Capsule and have gastric pH measurements taken
Exclusion criteria
* Any medical condition or history of such condition that may, in the opinion of the investigator, contraindicate participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve (AUC) of plasma GDC-0941 | 25 Days |
| Maximum plasma concentration (Cmax) of GDC-0941 | 25 Days |
| Relative bioavailability (Frel) according to the model independent approach | 25 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 25 days |
| Electrocardiogram (ECG) | 25 days |
Countries
United States
Outcome results
None listed