Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase I, open-label, randomized, 3-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy volunteers. In addition, the influence of food on ipatasertib exposure will also be determined. Participants will be randomized to one of six treatment sequences to receive three treatments of a single oral administration of ipatasertib in, 1) tablet formulation in the fasted state, 2) capsule formulation in the fasted state or 3) tablet formulation in the fed state. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 3 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Tablet/Capsule/Tablet with food | Experimental | Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after high-fat meal. |
|
| Sequence 2: Tablet/Tablet with food/Capsule | Experimental | Day 1: ipatasertib tablet administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib capsule administered after fast. |
|
| Sequence 3: Capsule/Tablet/Tablet with food | Experimental | Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib tablet administered after high-fat meal. |
|
| Sequence 4: Capsule/Tablet with food/Tablet | Experimental | Day 1: ipatasertib capsule administered after fast, Day 8: ipatasertib tablet administered after high-fat meal, Day 15: ipatasertib tablet administered after fast. |
|
| Sequence 5: Tablet with food/Tablet/Capsule |
| 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 |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Ipatasertib | Days 1, 8 and 15 | |
| Time to Maximum Concentration (tmax) of Ipatasertib | Days 1, 8 and 15 | |
| Area Under the Concentration-time Curve (AUC) from Hour 0 to the Last Quantifiable Concentration (AUC0-t) of Ipatasertib | Days 1, 8 and 15 | |
| Area Under the Concentration-time Curve (AUC) from Hour 0 Extrapolated to Infinity | Days 1, 8 and 15 | |
| Apparent Terminal Elimination Half-Life (t1/2) of Ipatasertib | Days 1, 8 and 15 | |
| Apparent Total Clearance (CL/F) of Ipatasertib | Days 1, 8 and 15 | |
| Apparent Volume of Distribution (Vz/F) of Ipatasertib | Days 1, 8 and 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events | From check in (Day -1) to 30 days after the last dose of study drug |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Clinically significant findings from medical history or screening evaluations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madison | Wisconsin | 53704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34471960 | Derived | Malhi V, Budha N, Sane R, Huang J, Liederer B, Meng R, Patel P, Deng Y, Cervantes A, Tabernero J, Musib L. Single- and multiple-dose pharmacokinetics, potential for CYP3A inhibition, and food effect in patients with cancer and healthy subjects receiving ipatasertib. Cancer Chemother Pharmacol. 2021 Dec;88(6):921-930. doi: 10.1007/s00280-021-04344-9. Epub 2021 Sep 1. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C583616 | ipatasertib |
| D002214 | Capsules |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib tablet administered after fast, Day 15: ipatasertib capsule administered after fast. |
|
| Sequence 6: Tablet with food/Capsule/Tablet | Experimental | Day 1: ipatasertib tablet administered after high-fat meal, Day 8: ipatasertib capsule administered after fast, Day 15: ipatasertib tablet administered after fast. |
|
|
| Ipatasertib (tablet) | Drug | Orally administered single dose of Ipatasertib formulated as a tablet. |
|
|