Trial · NCT03650400
Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma
NCT03650400, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2020-07-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma. Trials, record NCT03650400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03650400
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics, Safety and Tolerability of Fevipiprant Delivered Via a Once Daily Chewable Tablet in Children Aged 6 to < 12 Years With Asthma
- NCT number
- NCT03650400
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Asthma
- Interventions
- Fevipiprant
- First posted
- 2018-08-28
- Last updated
- 2026-01-13
- Results first posted
- 2020-07-20
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | Area under the curve (AUC0-24h,ss), steady state following drug administration |
| Primary | Pharmacokinetics of Fevipiprant by Maximum Plasma Concentration at Steady State (Cmax,ss), After at Least Four Consecutive Days of Dosing | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | Maximum plasma concentration (Cmax,ss) steady state following drug administration. |
| Primary | Pharmacokinetics of Fevipiprant by Oral Clearance at Steady State (CL/F), After at Least Four Consecutive Days of Dosing | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | Oral clearance (CL/F), steady state following drug administration. |
| Secondary | Pharmacokinetics of Fevipiprant by CL/F | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours. | Pharmacokinetics of fevipiprant by oral clearance (CL/F) at steady state |
| Secondary | Pharmacokinetics of Fevipiprant by Tmax,ss | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | Pharmacokinetics of fevipiprant by time of maximum plasma concentration (Tmax,ss) at steady state |
| Secondary | Urinary Excretion of Fevipiprant | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours. | CLr, amount and fraction of dose excreted over the PK collection interval at steady state, of fevipiprant |
| Secondary | Pharmacokinetics of Fevipiprant by Cmin,ss | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | Pharmacokinetics of fevipiprant by minimum plasma concentration (Cmin,ss) at steady state |
| Secondary | Pharmacokinetics of the Metabolite CCN362 by AUC0-24h,ss | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | Pharmacokinetics of CCN362 metabolite of fevipiprant , area under the curve (AUC0-24h,ss) at steady state. |
| Secondary | Pharmacokinetics of the Metabolite CCN362 by Cmax,ss | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | Pharmacokinetics of CCN362 metabolite of fevipiprant by maximum plasma concentration (Cmax,ss) at steady state |
| Secondary | Pharmacokinetics of the Metabolite CCN362 by Cmin,ss | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | Pharmacokinetics of CCN362 metabolite of fevipiprant by minimum plasma concentration (Cmin,ss) at steady state |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination. | h*ng/mL | MEAN |
| PRIMARY | Pharmacokinetics of Fevipiprant by Maximum Plasma Concentration at Steady State (Cmax,ss), After at Least Four Consecutive Days of Dosing | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination. | ng/mL | MEAN |
| PRIMARY | Pharmacokinetics of Fevipiprant by Oral Clearance at Steady State (CL/F), After at Least Four Consecutive Days of Dosing | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination. | L/h | MEAN |
| SECONDARY | Pharmacokinetics of Fevipiprant by CL/F | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours. | All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination. | L/h | MEAN |
| SECONDARY | Pharmacokinetics of Fevipiprant by Tmax,ss | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination. | h | MEAN |
| SECONDARY | Urinary Excretion of Fevipiprant | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours. | All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination. | L/h | MEAN |
| SECONDARY | Pharmacokinetics of Fevipiprant by Cmin,ss | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetics of the Metabolite CCN362 by AUC0-24h,ss | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination. | h*ng/mL | MEAN |
| SECONDARY | Pharmacokinetics of the Metabolite CCN362 by Cmax,ss | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetics of the Metabolite CCN362 by Cmin,ss | End of Treatment (pre-dose, 0.5hours, 1 hour, 2 hours, 3 hours, 5 hours and 8 hours) | All treated participants with a valid PK measurement. No PK samples were collected for PK analysis in Cohort B due to early study termination. | ng/mL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Cohort A Fevipiprant 75 mg | 2380 | Standard Deviation 1880 | h*ng/mL | |
| Pharmacokinetics of Fevipiprant by Maximum Plasma Concentration at Steady State (Cmax,ss), After at Least Four Consecutive Days of Dosing | Cohort A Fevipiprant 75 mg | 394 | Standard Deviation 286 | ng/mL | |
| Pharmacokinetics of Fevipiprant by Oral Clearance at Steady State (CL/F), After at Least Four Consecutive Days of Dosing | Cohort A Fevipiprant 75 mg | 48.2 | Standard Deviation 32 | L/h | |
| Pharmacokinetics of Fevipiprant by CL/F | Cohort A Fevipiprant 75 mg | 48.2 | Standard Deviation 32.0 | L/h | |
| Pharmacokinetics of Fevipiprant by Tmax,ss | Cohort A Fevipiprant 75 mg | 1.42 | Standard Deviation 0.916 | h | |
| Urinary Excretion of Fevipiprant | Cohort A Fevipiprant 75 mg | 6.61 | Standard Deviation 4.88 | L/h | |
| Pharmacokinetics of Fevipiprant by Cmin,ss | Cohort A Fevipiprant 75 mg | 28.3 | Standard Deviation 13.8 | ng/mL | |
| Pharmacokinetics of the Metabolite CCN362 by AUC0-24h,ss | Cohort A Fevipiprant 75 mg | 2760 | Standard Deviation 1210 | h*ng/mL | |
| Pharmacokinetics of the Metabolite CCN362 by Cmax,ss | Cohort A Fevipiprant 75 mg | 302 | Standard Deviation 134 | ng/mL | |
| Pharmacokinetics of the Metabolite CCN362 by Cmin,ss | Cohort A Fevipiprant 75 mg | 33.6 | Standard Deviation 22.6 | ng/mL |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A Fevipiprant 75 mg | 6 | |
| Overall Study | STARTED | Cohort B Feviprant 375 mg | 5 | |
| Overall Study | COMPLETED | Cohort A Fevipiprant 75 mg | 6 | |
| Overall Study | COMPLETED | Cohort B Feviprant 375 mg | 0 | |
| Overall Study | NOT COMPLETED | Cohort A Fevipiprant 75 mg | 0 | |
| Overall Study | NOT COMPLETED | Cohort B Feviprant 375 mg | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A Fevipiprant 75 mg | 0 | 6 |
| Total, all-cause mortality | Cohort B Feviprant 375 mg | 0 | 5 |
| Total, other adverse events | Cohort A Fevipiprant 75 mg | 0 | 6 |
| Total, other adverse events | Cohort B Feviprant 375 mg | 0 | 5 |
| Total, serious adverse events | Cohort A Fevipiprant 75 mg | 0 | 6 |
| Total, serious adverse events | Cohort B Feviprant 375 mg | 0 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A Fevipiprant 75 mg vs Cohort B Feviprant 375 mg: deaths from any cause | Trial comparisons |
| Cohort A Fevipiprant 75 mg vs Cohort B Feviprant 375 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03650400
GET https://conductscience.org/api/trials/v1/NCT03650400/registered