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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipatasertib/[14C]-ipatasertib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Period 1 treatment | Drug | 200 mg oral ipatasertib followed 1 hour later by 80-mcg/800-nCi intravenous [14C]-ipatasertib on Day 1 of study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): apparent terminal elimination half-life | Period 2: Approximately 2 weeks | |
| Pharmacokinetics of ipatasertib (oral): apparent total clearance (CL/F) | Period 2: Approximately 2 weeks | |
| Pharmacokinetics of ipatasertib (oral): apparent volume of distribution (Vz/F) | Period 2: Approximately 2 weeks | |
| Elimination and pharmacokinetics: Total radioactivity concentration in whole blood, plasma, urine, and feces | Period 2: Approximately 2 weeks | |
| Bioavailability: Absolute bioavailability of ipatasertib (area under the concentration-time curve) | Period 1: Approximately 4 days | |
| Mass balance | Period 2: Approximately 2 weeks | |
| Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): maximum observed concentration (Cmax) | Period 2: Approximately 2 weeks | |
| Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): time to maximum observed concentration (Tmax) | Period 2: Approximately 2 weeks | |
| Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): area under the concentration-time curve from Hour 0 to the last measurable concentration (AUC0-t) | Period 2: Approximately 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of ipatasertib (oral and IV): terminal elimination rate constant adjusted for oral bioavailability as applicable | Period 1: Approximately 4 days | |
| Pharmacokinetics of ipatasertib (oral and IV): terminal elimination half-life adjusted for oral bioavailability as applicable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madison | Wisconsin | 53704 | United States |
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| Period 2 treatment | Drug | 200-mg/100-mcCi oral [14C]-ipatasertib on Day 15 of study |
|
| Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): area under the concentration-time curve extrapolated to infinity (AUC0-inf) | Period 2: Approximately 2 weeks |
| Pharmacokinetics of [14C]-ipatasertib/ipatasertib (oral): apparent terminal elimination rate constant | Period 2: Approximately 2 weeks |
| Period 1: Approximately 4 days |
| Pharmacokinetics of ipatasertib (oral and IV): total clearance adjusted for oral bioavailability as applicable | Period 1: Approximately 4 days |
| Pharmacokinetics of ipatasertib (oral and IV): volume of distribution adjusted for oral bioavailability as applicable | Period 1: Approximately 4 days |
| Safety: Incidence of adverse events | Approximately 4 weeks |
| Elimination and pharmacokinetics: Metabolite concentration(s) in plasma, urine, and feces | Period 2: Approximately 2 weeks |
| Pharmacokinetics of ipatasertib (oral and IV): Cmax | Period 1: Approximately 4 days |
| Pharmacokinetics of ipatasertib (oral and IV): Tmax | Period 1: Approximately 4 days |
| Pharmacokinetics of ipatasertib (oral and IV): AUC0-t | Period 1: Approximately 4 days |
| Pharmacokinetics of ipatasertib (oral and IV): AUC0-inf | Period 1: Approximately 4 days |