Pharmacokinetics of Fevipiprant (QAW039) in Patients With Hepatic Impairment Compared to Matched Healthy Subjects
NCT ID: NCT03048448
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
42 participants
INTERVENTIONAL
2017-05-31
2019-04-22
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Fevipiprant 450mg
450mg Film Coated Tablet
Fevipiprant
Single 450mg dose
Interventions
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Fevipiprant
Single 450mg dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\- 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Anaheim, California, United States
Novartis Investigative Site
Orlando, Florida, United States
Countries
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Related Links
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Results for CQAW039A2108 from the Novartis Clinical Trials Website
A Plain Language Trial Summary is available on novartisclinicatrials.com
Other Identifiers
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CQAW039A2108
Identifier Type: -
Identifier Source: org_study_id