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NCT03934502

Effect of Meal Composition and Timing on Evobrutinib Bioavailability

Completed Phase 1 Last updated 7 July 2020
What this trial tests

Phase 1 trial testing Evobrutinib in Healthy in 20 participants. Completed in 12 June 2019.

Timeline
15 April 2019
Primary endpoint
12 June 2019
12 June 2019

Quick facts

Lead sponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposeother
Enrollment20
Start date15 April 2019
Primary completion12 June 2019
Estimated completion12 June 2019
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate the Pharmacokinetics (PK) of the Phase II tablet formulation of Evobrutinib under fasted conditions, within 30 minutes after start of a light meal, one hour prior to start of a low-fat meal, and 2 hours after start of a low-fat meal.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Immune-related pulmonary toxicities of checkpoint inhibitors in non-small cell lung cancer: Diagnosis, mechanism, and treatment strategies.
    Guo X, Chen S, Wang X, Liu X. · · 2023 · cited 27× · PMID 37081866 · DOI 10.3389/fimmu.2023.1138483

Verify or expand the search:

Other trials of Evobrutinib

Trials testing the same drug.

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03934502.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing