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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: GDC-0941
* Drug: GDC-0941
* Drug: GDC-0941
* Drug: GDC-0941


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crossover sequence 1<br> | Drug: GDC-0941<br>* Single dose market image tablet of hardness 1<br>Drug: GDC-0941<br>* Single dose market image tablet of hardness 2<br>Drug: GDC-0941<br>* Single dose market image tablet of hardness 3<br>Drug: GDC-0941<br>* Single dose Phase 2 tablet formulation<br>|
| Experimental: Crossover sequence 2<br> | Drug: GDC-0941<br>* Single dose market image tablet of hardness 1<br>Drug: GDC-0941<br>* Single dose market image tablet of hardness 2<br>Drug: GDC-0941<br>* Single dose market image tablet of hardness 3<br>Drug: GDC-0941<br>* Single dose Phase 2 tablet formulation<br>|
| Experimental: Crossover sequence 3<br> | Drug: GDC-0941<br>* Single dose market image tablet of hardness 1<br>Drug: GDC-0941<br>* Single dose market image tablet of hardness 2<br>Drug: GDC-0941<br>* Single dose market image tablet of hardness 3<br>Drug: GDC-0941<br>* Single dose Phase 2 tablet formulation<br>|
| Experimental: Crossover sequence 4<br> | Drug: GDC-0941<br>* Single dose market image tablet of hardness 1<br>Drug: GDC-0941<br>* Single dose market image tablet of hardness 2<br>Drug: GDC-0941<br>* Single dose market image tablet of hardness 3<br>Drug: GDC-0941<br>* Single dose Phase 2 tablet formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve (AUC) of plasma GDC-0941 |  | 25 Days | 
| Maximum plasma concentration (Cmax) of GDC-0941 |  | 25 Days | 
| Relative bioavailability (Frel) according to the model independent approach |  | 25 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | 25 days | 
| Electrocardiogram (ECG) |  | 25 days |