Hepatic Insufficiency
Conditions
Brief summary
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.
Interventions
DRUGIpatasertib
A single oral dose of 100 mg ipatasertib will be administered.
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* In good health (except for specific inclusion criteria related to hepatic impairment), as determined by the Investigator, based on no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram, and vital signs * Females will not be pregnant or breastfeeding, and must be either postmenopausal or agree to use a study-approved method of contraception from the time of signing the informed consent until 30 days after discharge * Males will either be sterile or agree to use male condom with spermicide from check-in (Day -1) until 90 days following the dose of study drug 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve (AUC) from 0 to Infinity (AUC0-inf) of Ipatasertib | up to Day 15 | AUC0-inf is defined as AUC extrapolated from Hour 0 to infinity of ipatasertib in the plasma. |
| Maximum Observed Plasma Concentration (Cmax) of Ipatasertib | up to Day 15 | Maximum observed concentration of ipatasertib as determined by measuring drug concentration in blood samples over time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC from 0 to last measurable concentration (AUC0-t) | up to Day 15 | Area under the plasma concentration-time curve from Hour 0 to the last measurable concentration of ipatasertib. |
| Half-life (t1/2) of Ipatasertib | up to Day 15 | 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. |
| Percentage of Participants with Treatment-Emergent Adverse Events (AE) | up to Day 15 | 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. |
| Apparent Volume of Distribution (V/F) of Ipatasertib | up to Day 15 | Apparent volume of distribution (V/F) during the terminal phase of ipatasertib. |
| Apparent Plasma Clearance (CL/F) of Ipatasertib | Up to Day 15 | 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. |
| Time to Reach Maximum Observed Concentration (tmax) of Ipatasertib | up to Day 15 | Time from dose administration to observed maximum serum concentration for ipatasertib as determined by measuring drug concentration in blood samples over time. |
Countries
United States
Outcome results
None listed