A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/3/2016 |
| Start Date: | March 2015 |
| End Date: | April 2015 |
A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Ipatasertib (GDC-0068) Following a Single Oral Dose and to Investigate the Absolute Bioavailability Following Single Oral and Intravenous Doses in a Single Cohort of Healthy Male Subjects
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
