NCT02092831

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	GDC-0941	Single dose market image tablet of hardness 1
DRUG	GDC-0941	Single dose market image tablet of hardness 2
DRUG	GDC-0941	Single dose market image tablet of hardness 3
DRUG	GDC-0941	Single dose Phase 2 tablet formulation

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-03-20
• Last updated: 2016-11-02

Locations

1 site across 1 country: United States