Trial reportCPT: pharmacometrics & systems pharmacology2026
Population Pharmacokinetic Analysis of Brensocatib in Adult and Adolescent Patients With Non-Cystic Fibrosis Bronchiectasis.
Trial report in CPT: pharmacometrics & systems pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04594369 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study), which is not on this map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study
Who cites it
1 citing paper in PubMed.
- Pharmacokinetics and Safety of a Single Dose of Brensocatib in Participants with Hepatic Impairment and Matched Participants with Normal Hepatic Functions.Clinical pharmacokinetics · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
Brensocatib, a competitive and reversible oral DPP1 inhibitor, at 10 and 25 mg significantly reduced pulmonary exacerbation burden, and 25 mg also reduced lung function decline vs. placebo in patients with non-cystic fibrosis bronchiectasis, hereafter bronchiectasis, in ASPEN (NCT04594369). A population pharmacokinetic (PPK) model was developed to support brensocatib dose selection for adults and adolescents. Data from 11 clinical trials were pooled for analysis. The covariate model was developed via a stepwise approach. Clinical relevance of statistically significant covariates was assessed by simulated brensocatib exposure at steady state in various subgroups with different characteristics relative to a reference subject (healthy White male, 49 years, 70 kg, fasted, no concomitant medications). Covariate effects on brensocatib PK were evaluated. From 291 healthy participants and 807 patients, 11,643 brensocatib plasma concentrations were used for PPK model construction. Body weight was integrated using standard allometric scaling coefficients of 0.75 on total and intercompartment clearance (CL/F and Q/F) and 1.0 on central and peripheral volume of distribution (Vc/F and Vp/F). Statistically significant covariates included hepatic impairment, sex, race, and co-medication use (strong CYP3A and Pgp modulators) on CL/F; age on Vc/F; food effect on Ka; and co-medications (strong CYP3A and Pgp inhibitors) on relative bioavailability. Disease populations, renal impairment, and tablet formulations were not statistically significant covariates. The PPK model provided a robust fit to observed brensocatib concentration time profiles in bronchiectasis patients. No identified covariates were clinically relevant. This analysis supported brensocatib dosage of 10 and 25 mg in patients with bronchiectasis ≥ 12 years without dose adjustment.
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Registered trials
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