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

NCT03048448 | Completed Phase 1 FDA Drug

• 1 other identifier: CQAW039A2108
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatic Impairment

Keywords

Hepatic impairment,; Fevipiprant,; adults,; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics: Plasma concentration of Fevipiprant by AUClast

  AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration

  120 hours post-dose

• Pharmacokinetics: Plasma concentration of Fevipiprant by AUCinf

  AUCinf is the area under the plasma concentration-time curve from time zero to infinity

  120 hours post-dose

• Pharmacokinetics: Plasma concentration of Fevipiprant by Cmax

  Cmax is the observed maximum plasma concentration following drug administration

  120 hours post-dose

Secondary Outcomes (6)

• Relationship between plasma pharmacokinetics of Fevipiprant by AUClast and baseline hepatic function.

  120 hours post-dose

• Relationship between plasma pharmacokinetics of Fevipiprant by AUCinf and baseline hepatic function.

  120 hours post-dose

• Relationship between plasma pharmacokinetics of Fevipiprant by Cmax and baseline hepatic function.

  120 hours post-dose

• Pharmacokinetics of the metabolite CCN362 by AUClast

  120 hours post-dose

• Pharmacokinetics of the metabolite CCN362 by AUCinf

  120 hours post-dose

Study Arms (1)

Fevipiprant 450mg

EXPERIMENTAL

450mg Film Coated Tablet

Drug: Fevipiprant

Interventions

Fevipiprant DRUG

Single 450mg dose

Also known as: QAW039

Fevipiprant 450mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Anaheim, California, 92801, United States

Location

Novartis Investigative Site

Orlando, Florida, 32809, United States

Location

Related Links

• Results for CQAW039A2108 from the Novartis Clinical Trials Website
• A Plain Language Trial Summary is available on novartisclinicatrials.com

MeSH Terms

Interventions

fevipiprant

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 9, 2017
• Study Start: May 31, 2017
• Primary Completion: April 22, 2019
• Study Completion: April 22, 2019
• Last Updated: December 11, 2020

Record last verified: 2020-04

Locations

US (2)