Trial reportBritish journal of clinical pharmacology2026
Early clinical pharmacology evaluation of the novel anti-inflammatory macrolide, glasmacinal (EP395): tolerability, pharmacokinetics and drug interactions.
Trial report in British journal of clinical pharmacology, 2026. 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.
What it found
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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 First-in Man, Phase I Study Investigating the Safety and Tolerability of EP395 in Healthy Volunteers
An Open-label, Healthy Subject, Two-part Study to Assess the Effect of Verapamil on Systemic Exposure of EP395 (Part A), and to Assess the Effect of EP395 on Systemic Exposure of Midazolam and Digoxin (Part B)
Who cites it
2 citing papers in PubMed.
- Early clinical pharmacology evaluation of the novel anti-inflammatory macrolide, glasmacinal (EP395): tolerability, pharmacokinetics and drug interactions.British journal of clinical pharmacology · 2026Trial
- Impact of the anti-inflammatory macrolide glasmacinal on the gut microbiota of healthy adults: an open-label trial.Nature communications · 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
6 authors.
Funding
Abstract
aimsThis work assessed the pharmacokinetics (PK), safety and tolerability of glasmacinal (EP395, an oral anti-inflammatory macrolide with negligible antimicrobial activity in development for COPD treatment) in two healthy participant trials: 'first-in-human' (FIH) and 'drug-drug-interaction' (DDI).
methodsThe FIH trial was a randomized, double-blind, placebo-controlled trial of single (20-750 mg) and multiple (120-375 mg daily for 28 days) doses of glasmacinal. The DDI trial was an open-label assessment of the effect of verapamil (moderate CYP3A4 inhibitor and P-gp inhibitor) on the PK of glasmacinal, and the effect of glasmacinal on the PK of midazolam (CYP3A4 substrate) and digoxin (P-gp substrate).
resultsNo SAEs or severe AEs occurred, and no AEs considered related to glasmacinal led to withdrawal. Glasmacinal was rapidly absorbed, reaching peak plasma concentrations at ~4 h post-dose and a terminal half-life ~70 h. Glasmacinal systemic exposure (C
conclusionsGlasmacinal was well tolerated in single doses up to 750 mg and repeat doses up to 375 mg. Glasmacinal may be a victim of selected drugs that impact CYP3A4 and/or P-gp but is unlikely to be a perpetrator of clinically relevant DDIs.
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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.