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NCT Number: NCT02092831

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-0941

Drug

Single dose market image tablet of hardness 1

Primary outcomes

  1. Area under the concentration-time curve (AUC) of plasma GDC-0941

    Time frame: 25 Days

  2. Maximum plasma concentration (Cmax) of GDC-0941

    Time frame: 25 Days

  3. Relative bioavailability (Frel) according to the model independent approach

    Time frame: 25 days

Secondary outcomes

  1. Incidence of adverse events

    Time frame: 25 days

  2. Electrocardiogram (ECG)

    Time frame: 25 days

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 20, 2014
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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