Evidence map›Paper›PMID 40748778›Full record

ArticleClinical and translational science2025

Pharmacokinetics of Bocidelpar, ASP0367, in Renal and Hepatic Impairment: Results From Two Phase 1 Studies.

Megumi Iwai, Nakyo Heo, Kentaro Hashimoto, Sayuri Guro, Selina Moy, Anna Spence, Tomasz Wojtkowski, Lauren Benner, Melanie Helmick, Tong Zhu and 1 more

2 registry-linked trialsAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04942964 phase1completednot on this map

A Phase 1 Open-label Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP0367 Compared to Participants With Normal Hepatic Function

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2021 to 2022Enrolled25ConditionsHepatic Impairment, Healthy VolunteersArmsBocidelpar
NCT05117294 phase1completednot on this map

A Phase 1 Open Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ASP0367 in Participants With Renal Impairment Compared to Healthy Participants With Normal Renal Function

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2021 to 2022Enrolled13ConditionsRenal Impairment, Healthy VolunteersArmsBocidelpar
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

11 authors.

Megumi IwaiAstellas Pharma Inc., Tokyo, Japan.ORCID 0009-0009-4323-8266
Nakyo HeoAstellas Pharma Inc., Northbrook, Illinois, USA.
Kentaro HashimotoAstellas Pharma Inc., Tokyo, Japan.
Sayuri GuroAstellas Pharma Inc., Tokyo, Japan.
Selina MoyAstellas Pharma Inc., Northbrook, Illinois, USA.
Anna SpenceAstellas Pharma Inc., Northbrook, Illinois, USA.
Tomasz WojtkowskiAstellas Pharma Inc., Northbrook, Illinois, USA.
Lauren BennerAstellas Pharma Inc., Northbrook, Illinois, USA.ORCID 0009-0002-4718-8023
Melanie HelmickAstellas Pharma Inc., Northbrook, Illinois, USA.ORCID 0009-0006-2551-0164
Tong ZhuAstellas Pharma Inc., Northbrook, Illinois, USA.ORCID 0000-0002-9305-458X
Brian C FerslewAstellas Pharma Inc., Northbrook, Illinois, USA.ORCID 0009-0005-1885-9205

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Bocidelpar is a peroxisome proliferator-activated receptor δ modulator designed to address mitochondrial impairment. Two open-label, single-dose phase 1 studies (NCT05117294/NCT04942964) investigated the effect of severe renal or mild/moderate hepatic impairment on bocidelpar pharmacokinetics and safety. Adult participants received 75 mg bocidelpar and underwent serial blood and urine sampling over 4 days to evaluate the pharmacokinetics of bocidelpar. Thirteen participants were included in the renal cohort (severe impairment, n = 7; healthy participants, n = 6). A minimal increase was observed in the maximum concentration (C

Indexed as

CaproatesKidney DiseasesLiver DiseasesSulfatesAdultAgedCase-Control StudiesFemaleHumansImidazolesMaleMiddle AgedMitochondriaPPAR deltaYoung AdultCaproatesimidazoleImidazolesPPAR deltaSulfateshepaticpharmacokineticsphase Irenal

Identifiers

PMID40748778
PMCPMC12315851

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.