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Pharmacokinetics and Safety of Fevipiprant in Patients With Renal Impairment Compared to Matched Healthy Subjects

NCT ID: NCT03087942

Last Updated: 2020-12-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-05

Study Completion Date

2018-08-07

Brief Summary

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The aim of the study is to assess whether renal impairment could affect fevipiprant pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient population.

The study also aims to determine the effect of dialysis on the fevipiprant pharmacokinetic profile as the procedure might remove a significant fraction of the drug.

Detailed Description

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The purpose of this study is to determine if the pharmacokinetic profile of fevipiprant is different in patients with renal impariment 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

Conditions

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Renal Insufficiency

Keywords

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end stage renal disase ESRD dialysis effect on pharmacokinetics PK renal impairment

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

ESRD patients

Group Type EXPERIMENTAL

QAW039

Intervention Type DRUG

450 mg

Group 2

healthy volunteers

Group Type EXPERIMENTAL

QAW39A

Intervention Type DRUG

450 mg

Group 3

severe and moderate renal impaired patients

Group Type EXPERIMENTAL

QAW39A2107

Intervention Type DRUG

450 mg

Group 4

mild renal impaired patients

Group Type EXPERIMENTAL

QAW39A2107

Intervention Type DRUG

450 mg

Interventions

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QAW039

450 mg

Intervention Type DRUG

QAW39A

450 mg

Intervention Type DRUG

QAW39A2107

450 mg

Intervention Type DRUG

QAW39A2107

450 mg

Intervention Type DRUG

Other Intervention Names

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fevipiprant fevipiprant fevipiprant fevipiprant

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects must satisfy the criteria for normal renal function as evidenced by normal Glomerular Filtration Rate (GFR): eGFR ≥ 90 mL/min/1.73m2; each healthy subject must match in age (+/- 10years), gender, smoking status, and weight (+/- 15%), a patient from the renail impaired patient groups:
* A body mass index (BMI) within the range of 18 - 36 kg/m2
* ESRD patients on hemodialysis: an glomerulo filtration rat GFR of \< 15 mL/min/1.73 m2
* patients with severe renal impairment: GFR of\< 30 mL/min/1.73m2 (without need of hemodialysis);
* patients with moderate renal impairment: 30 mL/min/1.73m2 ≤ eGFR \< 60 mL/min/1.73m2;
* patients with mild impairment: 60 mL/min/1.73m2 ≤ eGFR \< 90 mL/min/1.73m2

Exclusion Criteria

* Pregnant or nursing (lactating) women
* History or evidence of any inherited bilirubin disease or disorder
* subjects participating in another study
* malignancies in the past
* Hemoglobin levels below 10 g/dL at screening
* HIV positiv
* Heavy smokers (≥20 cigarettes per day)
* Liver disease, as indicated by ALT, γ-GT, AST and alkaline phosphatase which should not exceed twice the upper limit of normal and should be stable (e.g. increased liver values known from previous patient records). Serum bilirubin \> 27 μmol/L (1.6 mg/dL)
* Clinically significant ECG changes and/or arrhythmias
* Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Orlando, Florida, United States

Site Status

Novartis Investigative Site

Grünstadt, , Germany

Site Status

Countries

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United States Germany

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17506

Results for CQAW039A2107 can be found on the Novartis Clinical Trial Results Website

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=289

A Plain Language Trial Summary is available on novartisclinicatrials.com

Other Identifiers

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2016-004218-81

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQAW039A2107

Identifier Type: -

Identifier Source: org_study_id