Pharmacokinetics of Fevipiprant (QAW039) in Patients With Hepatic Impairment Compared to Matched Healthy Subjects

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

This study will characterize the pharmacokinetics (PK) of QAW039 after a single oral dose of QAW039 in patients with hepatic impairment compared to healthy matched control subjects.

Key facts

Study ID

NCT03048448

Run by

Novartis Pharmaceuticals

People needed

42

Starts

2017-05-31

Expected to finish

2019-04-22

Last updated by the study team

2020-12-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All subjects
• Weight of 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
• Patients with hepatic impairment
• Moderate hepatic impairment (Group 1): Child-Pugh Class B (7-9 points),
• Severe hepatic impairment (Group 2): Child-Pugh Class C (10-15 points
• Mild hepatic impairment (Group 4): Child-Pugh Class A (5-6 points)
• Healthy subjects
• Match in age (±5 years), gender, smoking status, and weight (± 15%) to an individual patient.
• In good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis at screening.

You may not qualify if…

• All subjects
• History of hypersensitivity and/or idiosyncracies to QAW039 or to drugs of similar classes (CRTh2 antagonists).
• Use of co-medications that may impact QAW039 exposure such as broad range UGT inhibitors or strong inhibitors of OAT3, OATP1B3, and P-gp, including but not limited to probenecid, ritonavir, valproic acid, and rifampin
• Surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential
• Patients with hepatic impairment
• Hepatic impairment due to non-liver disease (e.g., right heart failure)
• Current symptoms or history of encephalopathy Grade III or IV within the past 6 months
• Primary biliary liver cirrhosis and biliary obstruction
• Emergency room visit or hospitalization due to liver disease within the preceding 3 months.
• Severe complications of liver disease within the preceding 3 months.
• Healthy subjects
• Liver disease or liver injury as indicated by abnormal liver function tests.
• Any single parameter of ALT, AST, γ-GT, alkaline phosphatase or serum bilirubin must not exceed 1.5 x upper limit of normal (ULN)
• Any elevation above ULN of more than one parameter of ALT, AST, γ GT, alkaline phosphatase or serum bilirubin will exclude a subject from participation in the study
• A positive Hepatitis B surface antigen or Hepatitis C test result.

Where it is running

• Novartis Investigative Site — Anaheim, California, United States
• Novartis Investigative Site — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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