Healthy Volunteer
Conditions
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.
Interventions
Orally administered single dose of Ipatasertib formulated as a capsule.
Orally administered single dose of Ipatasertib formulated as a tablet.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration time curve (AUC) of ipatasertib | Days 1-13 |
| Maximum concentration (Cmax) reached of ipatasertib | Days 1-13 |
| Time to maximum concentration (Tmax) of ipatasertib | Days 1-13 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | From check-in (Day -1) to Day 13 |
Countries
United States
Outcome results
None listed