Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-02-22 @ 4:30 AM
Study NCT ID:
NCT03934502
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2019-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Meal Composition and Timing on Evobrutinib Bioavailability
Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-000877-21 | EUDRACT_NUMBER | None | View |