Trial · NCT05090904
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis
NCT05090904, Phase 2, Completed, Insmed Incorporated; results first posted 2026-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis. Trials, record NCT05090904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05090904
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis
- NCT number
- NCT05090904
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Insmed Incorporated
- Conditions
- Cystic Fibrosis
- Interventions
- Brensocatib, Placebo
- First posted
- 2021-10-25
- Last updated
- 2026-03-12
- Results first posted
- 2026-03-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1 | Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 | |
| Primary | Cmax of Brensocatib on Day 28 | Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28 | |
| Primary | Time to Maximum Plasma Concentration (Tmax) of Brensocatib on Day 1 | Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 | |
| Primary | Tmax of Brensocatib on Day 28 | Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28 | |
| Primary | Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of Brensocatib in Plasma on Day 1 | Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 | |
| Primary | AUC0-24 of Brensocatib in Plasma on Day 28 | Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 28 | |
| Primary | Elimination Half-life (t1/2) of Brensocatib in Plasma on Day 28 | Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28 | |
| Primary | Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | Up to Day 56 | A TEAE is defined as any adverse event (AE) that occurred after the first dose of study investigational medicinal product (IMP) and within 28 days after the last dose of study IMP. |
| Secondary | Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib Cmax After Administration of Brensocatib on Days 1 and 28 | Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose | Analysis of dose dependency for brensocatib Cmax was performed using a power law model. The logarithm of the Cmax was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope \* log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship. |
| Secondary | Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib AUC0-24 After Administration of Brensocatib on Days 1 and 28 | Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose | Analysis of dose dependency for brensocatib AUC0-24 was performed using a power law model. The logarithm of the AUC0-24 was linearly related to the logarithm of the dose using a linear regression analysis. Slope of the regression and corresponding 90% CIs are presented. Slope (90% CI): log(PK parameter) = intercept + slope \* log(dose) + error term, for relationship between each of the dose levels. All 3 dose levels are included in the same model for the dose-exposure relationship. |
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 | Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1 | Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 | Pharmacokinetic (PK) Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Cmax of Brensocatib on Day 28 | Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28 | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Overall number analyzed is the number of participants with data available for analyses. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Time to Maximum Plasma Concentration (Tmax) of Brensocatib on Day 1 | Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. | hours | MEDIAN |
| PRIMARY | Tmax of Brensocatib on Day 28 | Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28 | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Overall number analyzed is the number of participants with data available for analyses. | hours | MEDIAN |
| PRIMARY | Area Under the Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC0-24) of Brensocatib in Plasma on Day 1 | Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1 | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. | hours*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | AUC0-24 of Brensocatib in Plasma on Day 28 | Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 28 | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Overall number analyzed is the number of participants with data available for analyses. | hours*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Elimination Half-life (t1/2) of Brensocatib in Plasma on Day 28 | Predose and at 0.5, 1, 2, 4, 6, 8, 24, and 168 hours postdose on Day 28 | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Overall number analyzed is the number of participants with data available for analyses. | hours | GEOMETRIC_MEAN |
| PRIMARY | Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) | Up to Day 56 | Safety Analysis Set included all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib Cmax After Administration of Brensocatib on Days 1 and 28 | Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, 24 and 168 hours postdose | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Number analyzed signifies the number of participants with data available for analysis at the specified time point. | log(ng/ml) per log(mg) | NUMBER |
| SECONDARY | Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib AUC0-24 After Administration of Brensocatib on Days 1 and 28 | Day 1: Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose; Day 28: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hours postdose | PK Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter. Number analyzed signifies the number of participants with data available for analysis at the specified time point. | log(ng*h/mL) per log(mg) | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1 | Brensocatib 10 mg | 62.4 | Geometric Coefficient of Variation 41.3 | nanograms per milliliter (ng/mL) | |
| Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1 | Brensocatib 25 mg | 136 | Geometric Coefficient of Variation 25.9 | nanograms per milliliter (ng/mL) | |
| Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1 | Brensocatib 40 mg | 338 | Geometric Coefficient of Variation 17.7 | nanograms per milliliter (ng/mL) | |
| Cmax of Brensocatib on Day 28 | Brensocatib 10 mg | 86.2 | Geometric Coefficient of Variation 33.1 | ng/mL | |
| Cmax of Brensocatib on Day 28 | Brensocatib 25 mg | 234 | Geometric Coefficient of Variation 37.5 | ng/mL | |
| Cmax of Brensocatib on Day 28 | Brensocatib 40 mg | 469 | Geometric Coefficient of Variation 34.0 | ng/mL | |
| Time to Maximum Plasma Concentration (Tmax) of Brensocatib on Day 1 | Brensocatib 10 mg | 2.0 | Full Range 1.0 to 24.8 | hours | |
| Time to Maximum Plasma Concentration (Tmax) of Brensocatib on Day 1 | Brensocatib 25 mg | 1.5 | Full Range 1.0 to 4.1 | hours | |
| Time to Maximum Plasma Concentration (Tmax) of Brensocatib on Day 1 | Brensocatib 40 mg | 1.5 | Full Range 0.6 to 24.9 | hours | |
| Tmax of Brensocatib on Day 28 | Brensocatib 10 mg | 1.9 | Full Range 0.5 to 4.0 | hours |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brensocatib 10 mg | 8 | |
| Overall Study | STARTED | Brensocatib 25 mg | 8 | |
| Overall Study | STARTED | Brensocatib 40 mg | 8 | |
| Overall Study | STARTED | Placebo | 5 | |
| Overall Study | COMPLETED | Brensocatib 10 mg | 8 | |
| Overall Study | COMPLETED | Brensocatib 25 mg | 8 | |
| Overall Study | COMPLETED | Brensocatib 40 mg | 8 | |
| Overall Study | COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Brensocatib 10 mg | 0 | |
| Overall Study | NOT COMPLETED | Brensocatib 25 mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events136
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | Brensocatib 10 mg | 2 | 8 | |
| other | Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | Brensocatib 25 mg | 0 | 8 | |
| other | Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | Brensocatib 40 mg | 1 | 8 | |
| other | Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | Placebo | 0 | 5 | |
| other | COVID-19 | Infections and infestations | Brensocatib 10 mg | 0 | 8 | |
| other | COVID-19 | Infections and infestations | Brensocatib 25 mg | 1 | 8 | |
| other | COVID-19 | Infections and infestations | Brensocatib 40 mg | 1 | 8 | |
| other | COVID-19 | Infections and infestations | Placebo | 0 | 5 | |
| other | Abdominal pain | Gastrointestinal disorders | Brensocatib 10 mg | 0 | 8 | |
| other | Abdominal pain | Gastrointestinal disorders | Brensocatib 25 mg | 0 | 8 |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brensocatib 10 mg | 0 | 8 |
| Total, all-cause mortality | Brensocatib 25 mg | 0 | 8 |
| Total, all-cause mortality | Brensocatib 40 mg | 0 | 8 |
| Total, all-cause mortality | Placebo | 0 | 5 |
| Total, other adverse events | Brensocatib 10 mg | 4 | 8 |
| Total, other adverse events | Brensocatib 25 mg | 5 | 8 |
| Total, other adverse events | Brensocatib 40 mg | 4 | 8 |
| Total, other adverse events | Placebo | 2 | 5 |
| Total, serious adverse events | Brensocatib 10 mg | 0 | 8 |
| Total, serious adverse events | Brensocatib 25 mg | 0 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40753522 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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