A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects
Completed · Phase 1
Conditions studied: Healthy Volunteer
In brief
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.
Key facts
- Study ID
- NCT02390492
- Run by
- Genentech, Inc.
- People needed
- 8
- Starts
- 2015-03-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Healthy male volunteers 18 to 55 years of age, inclusive
- Body mass index (BMI) 18 to 32 kg/m2, inclusive
You may not qualify if…
- 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
Where it is running
- Study site — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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