Trial · NCT05090904
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| 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 | |
| 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 | Analysis of dose dependency for brensocatib AUClast was performed using a power law model. The logarithm of the AUClast 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. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05090904/registered