A Study of the Effect of Formulation and Tablet Hardness on the Bioavailability of Pictilisib in Healthy Volunteers
Completed · Phase 1
Conditions studied: Healthy Volunteer
In brief
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.
Key facts
- Study ID
- NCT02092831
- Run by
- Genentech, Inc.
- People needed
- 24
- Starts
- 2014-04-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- Any medical condition or history of such condition that may, in the opinion of the investigator, contraindicate participation in this study
Where it is running
- Study site — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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