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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092831
• Other study ID #: GP29284
• Status: Completed
• Phase: Phase 1
• First received: March 18, 2014
• Last updated: November 1, 2016
• Start date: April 2014
• Est. completion date: May 2014

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• GDC-0941
Single dose market image tablet of hardness 1
• GDC-0941
Single dose market image tablet of hardness 2
• GDC-0941
Single dose market image tablet of hardness 3
• GDC-0941
Single dose Phase 2 tablet formulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve (AUC) of plasma GDC-0941		25 Days	No
Primary	Maximum plasma concentration (Cmax) of GDC-0941		25 Days	No
Primary	Relative bioavailability (Frel) according to the model independent approach		25 days	No
Secondary	Incidence of adverse events		25 days	No
Secondary	Electrocardiogram (ECG)		25 days	No