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

• Status: Completed
• Trial end date: 2019-04-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Indoleacetic Acids

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.