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Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma

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: NCT03650400
Recruitment Status : Terminated (Company Decision)
First Posted : August 28, 2018
Results First Posted : July 20, 2020
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Intervention Drug: Fevipiprant
Enrollment 11
Recruitment Details Six US centers recruited 11 subjects in the study.
Pre-assignment Details A total of 19 subjects were screened to enroll 11 subjects in the study
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description QAW039 75 mg Chewable tablet QAW039 375 mg Chewable tablet
Period Title: Overall Study
Started 6 5
Completed 6 0
Not Completed 0 5
Reason Not Completed
Study terminated by sponsor             0             5
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg Total
Hide Arm/Group Description QAW039 75 mg Chewable tablet QAW039 375 mg Chewable tablet Total of all reporting groups
Overall Number of Baseline Participants 6 5 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 5 participants 11 participants
8.2  (1.83) 9.4  (1.52) 8.7  (1.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Female
4
  66.7%
3
  60.0%
7
  63.6%
Male
2
  33.3%
2
  40.0%
4
  36.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
6
 100.0%
4
  80.0%
10
  90.9%
More than one race
0
   0.0%
1
  20.0%
1
   9.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Pharmacokinetics of Fevipiprant by Area Under the Curve From 0 to 24 Hours at Steady State (AUC0-24h,ss), After at Least Four Consecutive Days of Dosing
Hide Description Area under the curve (AUC0-24h,ss), steady state following drug administration
Time Frame End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description:
QAW039 75 mg Chewable tablet
QAW039 375 mg Chewable tablet
Overall Number of Participants Analyzed 6 0
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
2380  (1880)
2.Primary Outcome
Title Pharmacokinetics of Fevipiprant by Maximum Plasma Concentration at Steady State (Cmax,ss), After at Least Four Consecutive Days of Dosing
Hide Description Maximum plasma concentration (Cmax,ss) steady state following drug administration.
Time Frame End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description:
QAW039 75 mg Chewable tablet
QAW039 375 mg Chewable tablet
Overall Number of Participants Analyzed 6 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
394  (286)
3.Primary Outcome
Title Pharmacokinetics of Fevipiprant by Oral Clearance at Steady State (CL/F), After at Least Four Consecutive Days of Dosing
Hide Description Oral clearance (CL/F), steady state following drug administration.
Time Frame End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description:
QAW039 75 mg Chewable tablet
QAW039 375 mg Chewable tablet
Overall Number of Participants Analyzed 6 0
Mean (Standard Deviation)
Unit of Measure: L/h
48.2  (32)
4.Secondary Outcome
Title Pharmacokinetics of Fevipiprant by CL/F
Hide Description Pharmacokinetics of fevipiprant by oral clearance (CL/F) at steady state
Time Frame End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description:
QAW039 75 mg Chewable tablet
QAW039 375 mg Chewable tablet
Overall Number of Participants Analyzed 6 0
Mean (Standard Deviation)
Unit of Measure: L/h
48.2  (32.0)
5.Secondary Outcome
Title Pharmacokinetics of Fevipiprant by Tmax,ss
Hide Description Pharmacokinetics of fevipiprant by time of maximum plasma concentration (Tmax,ss) at steady state
Time Frame End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description:
QAW039 75 mg Chewable tablet
QAW039 375 mg Chewable tablet
Overall Number of Participants Analyzed 6 0
Mean (Standard Deviation)
Unit of Measure: h
1.42  (0.916)
6.Secondary Outcome
Title Urinary Excretion of Fevipiprant
Hide Description CLr, amount and fraction of dose excreted over the PK collection interval at steady state, of fevipiprant
Time Frame End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description:
QAW039 75 mg Chewable tablet
QAW039 375 mg Chewable tablet
Overall Number of Participants Analyzed 6 0
Mean (Standard Deviation)
Unit of Measure: L/h
6.61  (4.88)
7.Secondary Outcome
Title Pharmacokinetics of Fevipiprant by Cmin,ss
Hide Description Pharmacokinetics of fevipiprant by minimum plasma concentration (Cmin,ss) at steady state
Time Frame End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description:
QAW039 75 mg Chewable tablet
QAW039 375 mg Chewable tablet
Overall Number of Participants Analyzed 6 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
28.3  (13.8)
8.Secondary Outcome
Title Pharmacokinetics of the Metabolite CCN362 by AUC0-24h,ss
Time Frame End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description:
QAW039 75 mg Chewable tablet
QAW039 375 mg Chewable tablet
Overall Number of Participants Analyzed 6 0
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
2760  (1210)
9.Secondary Outcome
Title Pharmacokinetics of the Metabolite CCN362 by Cmax,ss
Hide Description Pharmacokinetics of CCN362 metabolite of fevipiprant by maximum plasma concentration (Cmax,ss) at steady state
Time Frame End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description:
QAW039 75 mg Chewable tablet
QAW039 375 mg Chewable tablet
Overall Number of Participants Analyzed 6 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
302  (134)
10.Secondary Outcome
Title Pharmacokinetics of the Metabolite CCN362 by Cmin,ss
Hide Description Pharmacokinetics of CCN362 metabolite of fevipiprant by minimum plasma concentration (Cmin,ss) at steady state
Time Frame End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description:
QAW039 75 mg Chewable tablet
QAW039 375 mg Chewable tablet
Overall Number of Participants Analyzed 6 0
Mean (Standard Deviation)
Unit of Measure: ng/mL
33.6  (22.6)
11.Secondary Outcome
Title Pharmacokinetics of the Metabolite CCN362 by Tmax,ss
Hide Description Pharmacokinetics of CCN362 metabolite of fevipiprant by time of maximum plasma concentration (Tmax,ss) at steady state
Time Frame End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description:
QAW039 75 mg Chewable tablet
QAW039 375 mg Chewable tablet
Overall Number of Participants Analyzed 6 0
Mean (Standard Deviation)
Unit of Measure: h
2.69  (1.20)
12.Secondary Outcome
Title Urinary Excretion of the Metabolite, CCN362
Hide Description CLr, amount and fraction of dose excreted over the PK collection interval at steady state, of the metabolite, CCN362
Time Frame End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description:
QAW039 75 mg Chewable tablet
QAW039 375 mg Chewable tablet
Overall Number of Participants Analyzed 6 0
Mean (Standard Deviation)
Unit of Measure: L/h
5.10  (1.96)
Time Frame Adverse events (AEs) are presented from first dose of study treatment until last dose of study treatment plus 7 days post treatment. Serious AEs are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to maximum duration of 38 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Hide Arm/Group Description QAW039 75 mg Chewable tablet QAW039 375 mg Chewable tablet
All-Cause Mortality
Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Hide Serious Adverse Events
Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A Fevipiprant 75 mg Cohort B Feviprant 375 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 882 778 8300
EMail: Novartis.email@Novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT03650400    
Other Study ID Numbers: CQAW039B2201
First Submitted: August 27, 2018
First Posted: August 28, 2018
Results First Submitted: July 1, 2020
Results First Posted: July 20, 2020
Last Update Posted: December 2, 2020