Trial Outcomes & Findings for Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma (NCT NCT03650400)

NCT ID: NCT03650400

Last Updated: 2026-01-13

Results Overview

Area under the curve (AUC0-24h,ss), steady state following drug administration

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

Results posted on

2026-01-13

Participant Flow

Six US centers recruited 11 subjects in the study.

A total of 19 subjects were screened to enroll 11 subjects in the study

Participant milestones

Participant milestones
Measure	Cohort A Fevipiprant 75 mg QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
Overall Study STARTED	6	5
Overall Study COMPLETED	6	0
Overall Study NOT COMPLETED	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A Fevipiprant 75 mg QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
Overall Study Study terminated by sponsor	0	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A Fevipiprant 75 mg n=6 Participants QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg n=5 Participants QAW039 375 mg Chewable tablet	Total n=11 Participants Total of all reporting groups
Age, Continuous	8.2 years STANDARD_DEVIATION 1.83 • n=210 Participants	9.4 years STANDARD_DEVIATION 1.52 • n=19 Participants	8.7 years STANDARD_DEVIATION 1.74 • n=123 Participants
Sex: Female, Male Female	4 Participants n=210 Participants	3 Participants n=19 Participants	7 Participants n=123 Participants
Sex: Female, Male Male	2 Participants n=210 Participants	2 Participants n=19 Participants	4 Participants n=123 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Asian	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Black or African American	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants
Race (NIH/OMB) White	6 Participants n=210 Participants	4 Participants n=19 Participants	10 Participants n=123 Participants
Race (NIH/OMB) More than one race	0 Participants n=210 Participants	1 Participants n=19 Participants	1 Participants n=123 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=123 Participants

PRIMARY outcome

Timeframe: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

Population: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

Area under the curve (AUC0-24h,ss), steady state following drug administration

Outcome measures

Outcome measures
Measure	Cohort A Fevipiprant 75 mg n=6 Participants QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
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	2380 h*ng/mL Standard Deviation 1880	—

PRIMARY outcome

Timeframe: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

Population: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

Maximum plasma concentration (Cmax,ss) steady state following drug administration.

Outcome measures

Outcome measures
Measure	Cohort A Fevipiprant 75 mg n=6 Participants QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
Pharmacokinetics of Fevipiprant by Maximum Plasma Concentration at Steady State (Cmax,ss), After at Least Four Consecutive Days of Dosing	394 ng/mL Standard Deviation 286	—

PRIMARY outcome

Timeframe: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

Population: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

Oral clearance (CL/F), steady state following drug administration.

Outcome measures

Outcome measures
Measure	Cohort A Fevipiprant 75 mg n=6 Participants QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
Pharmacokinetics of Fevipiprant by Oral Clearance at Steady State (CL/F), After at Least Four Consecutive Days of Dosing	48.2 L/h Standard Deviation 32	—

SECONDARY outcome

Timeframe: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.

Population: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

Pharmacokinetics of fevipiprant by oral clearance (CL/F) at steady state

Outcome measures

Outcome measures
Measure	Cohort A Fevipiprant 75 mg n=6 Participants QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
Pharmacokinetics of Fevipiprant by CL/F	48.2 L/h Standard Deviation 32.0	—

SECONDARY outcome

Timeframe: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

Population: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

Pharmacokinetics of fevipiprant by time of maximum plasma concentration (Tmax,ss) at steady state

Outcome measures

Outcome measures
Measure	Cohort A Fevipiprant 75 mg n=6 Participants QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
Pharmacokinetics of Fevipiprant by Tmax,ss	1.42 h Standard Deviation 0.916	—

SECONDARY outcome

Timeframe: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.

Population: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

CLr, amount and fraction of dose excreted over the PK collection interval at steady state, of fevipiprant

Outcome measures

Outcome measures
Measure	Cohort A Fevipiprant 75 mg n=6 Participants QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
Urinary Excretion of Fevipiprant	6.61 L/h Standard Deviation 4.88	—

SECONDARY outcome

Timeframe: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

Population: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

Pharmacokinetics of fevipiprant by minimum plasma concentration (Cmin,ss) at steady state

Outcome measures

Outcome measures
Measure	Cohort A Fevipiprant 75 mg n=6 Participants QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
Pharmacokinetics of Fevipiprant by Cmin,ss	28.3 ng/mL Standard Deviation 13.8	—

SECONDARY outcome

Timeframe: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

Population: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

Pharmacokinetics of CCN362 metabolite of fevipiprant , area under the curve (AUC0-24h,ss) at steady state.

Outcome measures

Outcome measures
Measure	Cohort A Fevipiprant 75 mg n=6 Participants QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
Pharmacokinetics of the Metabolite CCN362 by AUC0-24h,ss	2760 h*ng/mL Standard Deviation 1210	—

SECONDARY outcome

Timeframe: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

Population: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

Pharmacokinetics of CCN362 metabolite of fevipiprant by maximum plasma concentration (Cmax,ss) at steady state

Outcome measures

Outcome measures
Measure	Cohort A Fevipiprant 75 mg n=6 Participants QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
Pharmacokinetics of the Metabolite CCN362 by Cmax,ss	302 ng/mL Standard Deviation 134	—

SECONDARY outcome

Timeframe: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

Population: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

Pharmacokinetics of CCN362 metabolite of fevipiprant by minimum plasma concentration (Cmin,ss) at steady state

Outcome measures

Outcome measures
Measure	Cohort A Fevipiprant 75 mg n=6 Participants QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
Pharmacokinetics of the Metabolite CCN362 by Cmin,ss	33.6 ng/mL Standard Deviation 22.6	—

SECONDARY outcome

Timeframe: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours)

Population: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

Pharmacokinetics of CCN362 metabolite of fevipiprant by time of maximum plasma concentration (Tmax,ss) at steady state

Outcome measures

Outcome measures
Measure	Cohort A Fevipiprant 75 mg n=6 Participants QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
Pharmacokinetics of the Metabolite CCN362 by Tmax,ss	2.69 h Standard Deviation 1.20	—

SECONDARY outcome

Timeframe: End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours.

Population: All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination.

CLr, amount and fraction of dose excreted over the PK collection interval at steady state, of the metabolite, CCN362

Outcome measures

Outcome measures
Measure	Cohort A Fevipiprant 75 mg n=6 Participants QAW039 75 mg Chewable tablet	Cohort B Feviprant 375 mg QAW039 375 mg Chewable tablet
Urinary Excretion of the Metabolite, CCN362	5.10 L/h Standard Deviation 1.96	—

Adverse Events

Cohort A Fevipiprant 75 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort B Feviprant 375 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 882 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER