Trial · NCT05090904
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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 |
| SECONDARY | AUClast of Brensocatib in Plasma 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. | hours*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Dose Proportionality of Brensocatib for Dose Levels 10mg to 40mg Using Brensocatib AUClast, 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*h/mL) per log(mg) | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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GET https://conductscience.org/api/trials/v1/NCT05090904/outcomes