Expired Study
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Madison, Wisconsin 53704


Purpose:

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.


Criteria:

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.


NCT ID:

NCT02536391


Primary Contact:

Study Director
Clinical Trials
Hoffmann-La Roche


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin 53704
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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