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

Genentech

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: GDC-0941

Study type: Interventional

Funder types: Industry

Identifiers

NCT02092831

GP29284

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Crossover sequence 1

Experimental group

Treatment:

Drug: GDC-0941

Drug: GDC-0941

Drug: GDC-0941

Drug: GDC-0941

Crossover sequence 2

Experimental group

Treatment:

Drug: GDC-0941

Drug: GDC-0941

Drug: GDC-0941

Drug: GDC-0941

Crossover sequence 3

Experimental group

Treatment:

Drug: GDC-0941

Drug: GDC-0941

Drug: GDC-0941

Drug: GDC-0941

Crossover sequence 4

Experimental group

Treatment:

Drug: GDC-0941

Drug: GDC-0941

Drug: GDC-0941

Drug: GDC-0941