Evidence map›Paper›PMID 39574348›Full record

ArticleBritish journal of clinical pharmacology2025

The pharmacokinetics of brensocatib in participants with renal impairment following a single oral administration.

Sam Au Yeung, Daniel S Stein, Thomas C Marbury, Helen Usansky

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase I
In one paragraph

Article in British journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05673603 (A Phase 1, Open-Label, Single Dose Parallel-Group Study of Brensocatib Following a Single Oral Administration in Subjects With or Without Renal Impairment), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

NCT05673603 phase1completednot on this map

A Phase 1, Open-Label, Single Dose Parallel-Group Study of Brensocatib Following a Single Oral Administration in Subjects With or Without Renal Impairment

TypeinterventionalSponsorInsmed IncorporatedRan2021 to 2023Enrolled28ConditionsRenal ImpairmentArmsBrensocatib
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Sam Au YeungInsmed Incorporated, Bridgewater, NJ, United States.
Daniel S SteinInsmed Incorporated, Bridgewater, NJ, United States.
Thomas C MarburyOrlando Clinical Research Center, Orlando, FL, United States.
Helen UsanskyInsmed Incorporated, Bridgewater, NJ, United States.

Funding

Insmed
6 · The paper itself

Abstract

aimBrensocatib is an oral, selective, competitive and reversible dipeptidyl peptidase 1 inhibitor in development for the treatment of bronchiectasis. This study evaluated the pharmacokinetics (PKs), safety and tolerability of brensocatib in participants with varying degrees of renal impairment and normal renal function.

methodsIn this phase 1, multicentre, open-label study, 28 participants with mild, moderate or severe renal impairment (estimated glomerular filtration rate [eGFR] 60 to <90, 30 to <60 and 15 to <30 mL/min/1.73 m

resultsDemographic and baseline characteristics were similar across groups. There were no significant differences between groups in brensocatib PK parameters. The mean coefficient of variation (CV) of elimination half-life of brensocatib was 37.0 (15.3), 42.8 (21.7), 36.3 (22.9) and 39.1 (17.8) h for mild, moderate, severe and normal renal function groups, respectively. Single-dose brensocatib was quickly absorbed; all groups had a median time to maximum observed plasma concentration of 1 h. Regression model analyses indicated no significant relationships between selected brensocatib PK parameters and eGFR. No treatment-emergent adverse events were reported during the study.

conclusionSingle-dose brensocatib was well tolerated. The study data do not indicate a significant effect of renal impairment on brensocatib elimination and systemic exposure, suggesting that dose adjustment of brensocatib is not necessary in participants with renal impairment. CLINICAL TRIAL REGISTRATION NUMBER: NCT05673603.

Indexed as

Dipeptidyl-Peptidase IV InhibitorsRenal InsufficiencyAdministration, OralAdultAgedFemaleGlomerular Filtration RateHalf-LifeHumansMaleMiddle AgedSeverity of Illness IndexDipeptidyl-Peptidase IV Inhibitorsclinical pharmacologypharmacokineticsphase 1respiratory medicine

Identifiers

PMID39574348
PMCPMC11992659

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.