Trial reportEuropean journal of drug metabolism and pharmacokinetics2026
Pharmacokinetics and Safety of Nerandomilast in Healthy Volunteers.
Trial report in European journal of drug metabolism and pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.
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.
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers (a Partially Randomised, Partially Single-blind, Placebo-controlled Phase I Study)
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d.for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)
A Phase I, Open-label, Non-randomized, Single-dose, Single-arm, Single-period Study to Investigate the Metabolism and Pharmacokinetics of [C-14]-Labelled BI 1015550 After Oral Administration in Healthy Male Subjects
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesNerandomilast, a preferential phosphodiesterase 4B inhibitor, is approved for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis in some countries. The objective of this study was to evaluate the safety and pharmacokinetics of nerandomilast in healthy volunteers through single- and multiple-rising-dose studies, and a human mass balance study evaluating absorption, distribution, metabolism, and excretion.
methodsHealthy participants received oral nerandomilast doses ranging from 0.02 mg to 24 mg in the single-rising-dose trial, 1 mg or 6 mg twice daily for 14 days in the multiple-rising-dose trial, and a single oral dose of 18 mg [
resultsNerandomilast was rapidly absorbed postadministration, with peak plasma concentrations occurring between 0.5 and 1.25 h postdose before declining in a multiphasic manner. Nerandomilast exposure increased dose proportionally following single- and multiple-dose administrations. Steady state was reached by day 7 after twice-daily dosing with up to 1.69-fold drug accumulation. Following a single oral dose administration of [
conclusionsNerandomilast exhibited rapid oral absorption, multiphasic elimination profile, dose-proportional exposure, and was excreted via urine and feces.
trial registrationNCT01594515 (registered 2012-05-07), NCT01835899 (registered 2013-04-11), and NCT04771286 (registered 2021-02-23).
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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.