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This Phase I, open-label, randomized, 2-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy adult volunteers. Participants will be randomized to one of two treatment sequences to receive a single oral administration of ipatasertib in tablet or capsule formulation followed, after a washout period, by a single oral administration of ipatasertib in the second formulation. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Tablet followed by Capsule | Experimental |
| |
| Sequence 2: Capsule followed by Tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ipatasertib (Capsule) | Drug | Orally administered single dose of Ipatasertib formulated as a capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve (AUC) of ipatasertib | Days 1-13 | |
| Maximum concentration (Cmax) reached of ipatasertib | Days 1-13 | |
| Time to maximum concentration (Tmax) of ipatasertib | Days 1-13 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | From check-in (Day -1) to Day 13 |
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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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| ID | Term |
|---|---|
| C583616 | ipatasertib |
| D002214 | Capsules |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| ipatasertib (Tablet) | Drug | Orally administered single dose of Ipatasertib formulated as a tablet. |
|