Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

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

Key facts

Study ID

NCT02624557

Run by

Novartis Pharmaceuticals

People needed

23

Starts

2015-12-21

Expected to finish

2017-10-01

Last updated by the study team

2020-12-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

Where it is running

• DaVita Clinical Research-Denver — Lakewood, Colorado, United States
• University of Miami / Clinical Research Services, Inc. — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• DaVita Clinical Research — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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