Evidence map›Paper›PMID 39920097›Full record

ArticleJournal of clinical pharmacology2025

Clinical Assessment of the Drug-Drug Interaction Potential of Omaveloxolone in Healthy Adult Participants.

Hamim Zahir, Masako Murai, Lucy Wu, Michelle Valentine, Scott Hynes

2 registry-linked trialsAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in 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 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT04008186 phase1completednot on this map

A Phase 1, Open-Label, 4-Part, Drug-Drug Interaction Study With Omaveloxolone in Healthy Subjects

TypeinterventionalSponsorBiogenRan2019 to 2019Enrolled61ConditionsHealthy Adult SubjectsArmsOmaveloxolone, Midazolam oral solution, Repaglinide 1 MG, MetFORMIN 500 Mg Oral Tablet, Rosuvastatin
NCT05909644 phase1completednot on this map

A Single Sequence, 2-Period, Open-label Crossover Study in Healthy Subjects to Determine the Effect of a Moderate CYP3A4 Inducer on the Pharmacokinetics of Omaveloxolone

TypeinterventionalSponsorBiogenRan2023 to 2023Enrolled20ConditionsHealthy Adult SubjectsArmsOmaveloxolone, Efavirenz
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Observational
  3. Review
  4. 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

5 authors.

Hamim ZahirBiogen, Inc., Cambridge, MA, USA.
Masako MuraiBiogen, Inc., Cambridge, MA, USA.
Lucy WuBiogen, Inc., Cambridge, MA, USA.
Michelle ValentineCelerion, Inc., Tempe, AZ, USA.
Scott HynesBiogen, Inc., Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Omaveloxolone is approved in the United States and the European Union for the treatment of patients with Friedreich ataxia aged ≥16 years. It is mainly metabolized by cytochrome P450 (CYP) 3A4 in vitro. Two drug-drug interaction studies (NCT04008186 and NCT05909644) were performed to evaluate (1) the effect of drug-metabolizing enzymes (DMEs) and drug transporter (DT) modulators on the pharmacokinetics of omaveloxolone and (2) the effect of omaveloxolone on the pharmacokinetics of DME and DT substrates. Additionally, the safety of coadministering these drugs with omaveloxolone was assessed. Coadministration of the strong CYP3A4 inhibitor itraconazole significantly increased omaveloxolone maximum plasma concentration (C

Indexed as

Cytochrome P-450 CYP3A InhibitorsItraconazoleTriterpenesAdultAlkynesArea Under CurveCross-Over StudiesCyclopropanesCytochrome P-450 CYP3ACytochrome P-450 CYP3A InducersDrug InteractionsFemaleHealthy VolunteersHumansMaleMiddle AgedAlkynesCyclopropanesCYP3A4 protein, humanCytochrome P-450 CYP3ACytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A InhibitorsItraconazoleomaveloxoloneTriterpenesCYP3A4drug–drug interactionFriedreich ataxiaomaveloxolonepharmacokinetics

Identifiers

PMID39920097
PMCPMC12110731

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.