Ipatasertib (GDC-0068) Study to Evaluate Formulation Change and Food Effect on Bioavailability in Healthy Subjects
- Registration Number
- NCT02536391
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This Phase I, open-label, randomized, 3-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be determined. Participants will be randomized to one of six treatment sequences to receive three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 3 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Healthy males or females, between 18 and 55 years of age, inclusive
- Body mass index between 18.5 and 29.9 kg/m^2, inclusive
Exclusion Criteria
- Clinically significant findings from medical history or screening evaluations.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 6: Tablet with food/Capsule/Tablet Ipatasertib (tablet) Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after fast. Sequence 3: Capsule/Tablet/Tablet with food Ipatasertib (tablet) Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib tablet administered after high-fat meal. Sequence 4: Capsule/Tablet with food/Tablet Ipatasertib (tablet) Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib tablet administered after fast. Sequence 4: Capsule/Tablet with food/Tablet Ipatasertib (capsule) Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib tablet administered after fast. Sequence 5: Tablet with food/Tablet/Capsule Ipatasertib (tablet) Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib capsule administered after fast. Sequence 1: Tablet/Capsule/Tablet with food Ipatasertib (capsule) Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after high-fat meal. Sequence 1: Tablet/Capsule/Tablet with food Ipatasertib (tablet) Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after high-fat meal. Sequence 2: Tablet/Tablet with food/Capsule Ipatasertib (capsule) Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib capsule administered after fast. Sequence 2: Tablet/Tablet with food/Capsule Ipatasertib (tablet) Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib capsule administered after fast. Sequence 3: Capsule/Tablet/Tablet with food Ipatasertib (capsule) Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib tablet administered after high-fat meal. Sequence 5: Tablet with food/Tablet/Capsule Ipatasertib (capsule) Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib capsule administered after fast. Sequence 6: Tablet with food/Capsule/Tablet Ipatasertib (capsule) Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after fast.
- Primary Outcome Measures
Name Time Method Maximum Observed Concentration (Cmax) of Ipatasertib Days 1, 8 and 15 Time to Maximum Concentration (tmax) of Ipatasertib Days 1, 8 and 15 Area Under the Concentration-time Curve (AUC) from Hour 0 to the Last Quantifiable Concentration (AUC0-t) of Ipatasertib Days 1, 8 and 15 Area Under the Concentration-time Curve (AUC) from Hour 0 Extrapolated to Infinity Days 1, 8 and 15 Apparent Terminal Elimination Half-Life (t1/2) of Ipatasertib Days 1, 8 and 15 Apparent Total Clearance (CL/F) of Ipatasertib Days 1, 8 and 15 Apparent Volume of Distribution (Vz/F) of Ipatasertib Days 1, 8 and 15
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events From check in (Day -1) to 30 days after the last dose of study drug