Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:5/6/2018
Start Date:December 21, 2015
End Date:October 1, 2017

Use our guide to learn which trials are right for you!

A Phase 1, Open-label, Single-dose, Multicenter, Parallel Group Study to Assess the Pharmacokinetics and Safety of Alpelisib (BYL719) in Subjects With Hepatic Impairment Compared to Matched Healthy Control Subjects.

To characterize the pharmacokinetics and safety of alpelisib in subjects with hepatic
impairment compared to matched healthy control subjects.


Inclusion Criteria:

-Other then hepatic impairment, subjects should be in good health as determined by past
medical history, physical examination, vital signs, electrocardiogram (except for
additional inclusion criteria for hepatic impaired subjects). -Subjects must weigh at least
50 kg and no more than 120 kg and have a body mass index in the range 18.0-36.0 kg/m2.

Additional criteria for hepatic impaired subjects: -Subjects must have a score clinically
determined and calculated as per the Child-Pugh classification and consistent with the
degree of hepatic impairment in which study is currently enrolling. -Stable Child-Pugh
status within 28 days prior to dosing.

Exclusion Criteria: All subjects:

- Subject has received a liver transplant at any time in the past and is on
immunosuppressant therapy.

- Smokers not willing to limit the use of tobacco to 10 cigarettes per day. -Surgical or
medical condition which might significantly alter the absorption, distribution,
metabolism, or excretion of drugs, or which may jeopardize the subject's safety in
case of participation in the study. -Use of any herbal medications/supplements.

History of acute pancreatitis within 1 year of study entry.

Additional criteria for subjects with normal liver function:

-Use of any prescription or non-prescription medication. -Positive Hepatitis B surface
antigen (HBsAg) or Hepatitis C test result.

Additional criteria for hepatic impaired subjects: -Use of any prescription or
non-prescription medication, that has the potential to interact with alpelisb. Concomitant
medications without potential to interact with alpelisib must be stable in dose.
-Encephalopathy grade 3 or worse. -Total bilirubin > 6 mg/dl. Screening or baseline ECG:
QTcF>480msec for both genders

Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
4
sites
825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
Principal Investigator: Jolene Berg
Phone: 612-347-6206
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
Principal Investigator: Thomas C. Marbury
Phone: 407-472-0227
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Lakewood, Colorado 80228
Principal Investigator: Robert Williams
Phone: 877-594-7526
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
Miami, Florida 33136
Principal Investigator: Richard A. Preston
Phone: 305-243-6795
?
mi
from
Miami, FL
Click here to add this to my saved trials