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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03048448
Recruitment Status : Completed
First Posted : February 9, 2017
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: Fevipiprant Phase 1

Detailed Description:
The purpose of this study is to determine if the pharmacokinetic profile of Fevipiprant is different in patients with hepatic impairment compared to healthy matched volunteers to an extent that would require an adjustment of the dosage. Data from this study will be used to guide enrollment criteria in future clinical trials and to support regulatory submission and labeling information.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of Fevipiprant (QAW039) in Patients With Hepatic Impairment Compared to Matched Healthy Subjects
Actual Study Start Date : May 31, 2017
Actual Primary Completion Date : April 22, 2019
Actual Study Completion Date : April 22, 2019

Arm Intervention/treatment
Experimental: Fevipiprant 450mg
450mg Film Coated Tablet
Drug: Fevipiprant
Single 450mg dose
Other Name: QAW039




Primary Outcome Measures :
  1. Pharmacokinetics: Plasma concentration of Fevipiprant by AUClast [ Time Frame: 120 hours post-dose ]
    AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration

  2. Pharmacokinetics: Plasma concentration of Fevipiprant by AUCinf [ Time Frame: 120 hours post-dose ]
    AUCinf is the area under the plasma concentration-time curve from time zero to infinity

  3. Pharmacokinetics: Plasma concentration of Fevipiprant by Cmax [ Time Frame: 120 hours post-dose ]
    Cmax is the observed maximum plasma concentration following drug administration


Secondary Outcome Measures :
  1. Relationship between plasma pharmacokinetics of Fevipiprant by AUClast and baseline hepatic function. [ Time Frame: 120 hours post-dose ]
    AUClast (the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ) related to Child Pugh score

  2. Relationship between plasma pharmacokinetics of Fevipiprant by AUCinf and baseline hepatic function. [ Time Frame: 120 hours post-dose ]
    AUCinf (the area under the plasma concentration-time curve from time zero to infinity) related to Child Pugh score

  3. Relationship between plasma pharmacokinetics of Fevipiprant by Cmax and baseline hepatic function. [ Time Frame: 120 hours post-dose ]
    Cmax is the observed maximum plasma concentration following drug administration related to Child Pugh score

  4. Pharmacokinetics of the metabolite CCN362 by AUClast [ Time Frame: 120 hours post-dose ]
    AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration

  5. Pharmacokinetics of the metabolite CCN362 by AUCinf [ Time Frame: 120 hours post-dose ]
    AUCinf is the area under the plasma concentration-time curve from time zero to infinity

  6. Pharmacokinetics of the metabolite CCN362 by Cmax [ Time Frame: 120 hours post-dose ]
    Cmax is the observed maximum plasma concentration following drug administration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048448


Locations
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United States, California
Novartis Investigative Site
Anaheim, California, United States, 92801
United States, Florida
Novartis Investigative Site
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03048448    
Other Study ID Numbers: CQAW039A2108
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hepatic impairment,
Fevipiprant,
adults,
pharmacokinetics
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases