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
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 1 study evaluating the pharmacokinetics, tolerability and safety of a single dose of ipatasertib in participants with mild, moderate or severe hepatic impairment compared to healthy participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Hepatic Function | Experimental | Participants with normal hepatic function will be administered a single oral dose of ipatasertib (100 mg). |
|
| Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) will be administered a single dose of ipatasertib (100 mg). |
|
| Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) will be administered a single dose of ipatasertib (100 mg). |
|
| Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) will be administered a single dose of ipatasertib (100 mg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipatasertib | Drug | A single oral dose of 100 mg ipatasertib will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve (AUC) from 0 to Infinity (AUC0-inf) of Ipatasertib | AUC0-inf is defined as AUC extrapolated from Hour 0 to infinity of ipatasertib in the plasma. | up to Day 15 |
| Maximum Observed Plasma Concentration (Cmax) of Ipatasertib | Maximum observed concentration of ipatasertib as determined by measuring drug concentration in blood samples over time. | up to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Treatment-Emergent Adverse Events (AE) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
Not provided
Inclusion Criteria:
Additional Inclusion Criteria for Healthy Subjects Only:
- Liver enzyme tests must be less than or equal to the upper limits of normal
Additional Exclusion Criteria for Hepatic Impaired Subjects Only:
- Hepatic impairment must have a Child-Pugh score of 5 to 6 (mild), 7 to 9 (moderate), or 10 to 15 (severe) and have stable hepatic insufficiency within 1 month prior to Screening
Exclusion Criteria:
Additional Exclusion Criteria for Healthy Subjects Only:
Additional Exclusion Criteria for Hepatic Impaired Subjects Only:
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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, Inc. | Miami | Florida | 33014 | United States | ||
| New Orleans Center for Clinical Research |
Not provided
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C583616 | ipatasertib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| up to Day 15 |
| Time to Reach Maximum Observed Concentration (tmax) of Ipatasertib | Time from dose administration to observed maximum serum concentration for ipatasertib as determined by measuring drug concentration in blood samples over time. | up to Day 15 |
| AUC from 0 to last measurable concentration (AUC0-t) | Area under the plasma concentration-time curve from Hour 0 to the last measurable concentration of ipatasertib. | up to Day 15 |
| Half-life (t1/2) of Ipatasertib | Half-life of ipatasertib is the time elapsed for the drug concentration to decrease by half as determined by measuring drug concentration in blood samples over time. | up to Day 15 |
| Apparent Plasma Clearance (CL/F) of Ipatasertib | Apparent clearance (CL/F) of ipatasertib, where CL is clearance and F is bioavailability (relative amount of extravascularly-administered drug that reaches systemic circulation unchanged). Determined by measuring drug concentration in blood samples over time. | Up to Day 15 |
| Apparent Volume of Distribution (V/F) of Ipatasertib | Apparent volume of distribution (V/F) during the terminal phase of ipatasertib. | up to Day 15 |
| Knoxville |
| Tennessee |
| 37920 |
| United States |
| American Research Corporation Inc. | San Antonio | Texas | 78215 | United States |