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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
A single oral dose of 100 mg ipatasertib will be administered.
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
American Research Corporation Inc.
San Antonio, Texas, United States
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.
Time frame: 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.
Time frame: up to Day 15
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Up to Day 15
Apparent Volume of Distribution (V/F) of Ipatasertib
Apparent volume of distribution (V/F) during the terminal phase of ipatasertib.
Time frame: up to Day 15