A Study of the Effect of Formulation and Tablet Hardness on the Bioavailability of Pictilisib in Healthy Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:8/3/2016
Start Date:April 2014
End Date:May 2014

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Trial Summary
Trial Overview
Inclusion Criteria

A PHASE 1, OPEN-LABEL STUDY TO EVALUATE THE EFFECT OF FORMULATION AND TABLET HARDNESS ON THE RELATIVE BIOAVAILABILITY OF PICTILISIB (GDC-0941) IN HEALTHY SUBJECTS

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.


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
We found this trial at
1
site
Clinical Trial Facility in Madison Wisconsin
Madison, Wisconsin 53792
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mi
from
Madison, WI
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