Expired Study
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Madison, Wisconsin 53704


Purpose:

This 2-period, open-label, nonrandomized study will be conducted to determine the absolute bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its metabolite(s). Healthy male participants will receive a single 200-mg oral dose of ipatasertib followed 1 hour later by an 80-mcg/800-nCi intravenous dose of [14C]-ipatasertib. After a 4-day observation period and 10-day washout, participants will receive a single 200-mg/100-mcCi oral dose of [14C]-ipatasertib with subsequent data collection for an additional 7 to 14 days until discharge criteria are met.


Criteria:

Inclusion Criteria: - Healthy male volunteers 18 to 55 years of age, inclusive - Body mass index (BMI) 18 to 32 kg/m2, inclusive Exclusion Criteria: - Females - Clinically significant findings from medical history or screening evaluations - Recent participation in any other investigational drug study or biologic agent study, or receipt of a previous radiolabeled investigational drug within 6 months prior to check-in - Significant radiation exposure within 12 months prior to check-in


NCT ID:

NCT02390492


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: November 20, 2017

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