A Study Evaluating the Effect of Formulation on the Bioavailability of Ipatasertib in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT02063581
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This Phase I, open-label, randomized, 2-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy adult volunteers. Participants will be randomized to one of two treatment sequences to receive a single oral administration of ipatasertib in tablet or capsule formulation followed, after a washout period, by a single oral administration of ipatasertib in the second formulation. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Healthy male and female volunteers aged 18 to 55 years, inclusive
- Body mass index (BMI) from 18.5-29.9 kg/m2, 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 1: Tablet followed by Capsule ipatasertib (Tablet) - Sequence 1: Tablet followed by Capsule ipatasertib (Capsule) - Sequence 2: Capsule followed by Tablet ipatasertib (Tablet) - Sequence 2: Capsule followed by Tablet ipatasertib (Capsule) -
- Primary Outcome Measures
Name Time Method Time to maximum concentration (Tmax) of ipatasertib Days 1-13 Area under the concentration time curve (AUC) of ipatasertib Days 1-13 Maximum concentration (Cmax) reached of ipatasertib Days 1-13
- Secondary Outcome Measures
Name Time Method Incidence of adverse events From check-in (Day -1) to Day 13