A Study of the Effect of Formulation and Tablet Hardness on the Bioavailability of Pictilisib in Healthy Volunteers
- Registration Number
- NCT02092831
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Crossover sequence 2 GDC-0941 - Crossover sequence 3 GDC-0941 - Crossover sequence 4 GDC-0941 - Crossover sequence 1 GDC-0941 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Incidence of adverse events 25 days Electrocardiogram (ECG) 25 days