NCT03934502

Effect of Meal Composition and Timing on Evobrutinib Bioavailability

Phase I, Open-Label, Randomized, Single-Dose, Four-Period, Four-Sequence Crossover Study to Compare the Effects of a Light Meal and of a Low-Fat Meal Timing on Evobrutinib Bioavailability in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Evobrutinib	Participants will receive single oral dose of evobrutinib either after an overnight fast of at least 10 hours (Treatment A), within 30 minutes after start of a light meal (Treatment B), 1 hour prior to a low-fat meal (Treatment C), or 2 hours after start of a low-fat meal (Treatment D).

Timeline

• Start date: 2019-04-15
• Primary completion: 2019-06-12
• Completion: 2019-06-12
• First posted: 2019-05-02
• Last updated: 2020-07-07

Locations

1 site across 1 country: Germany