Nuvisan GmbH
Neu-Ulm, 89231, Germany
NCT Number: NCT04697511
The study will investigate the effect of single dose and multiple doses of M2951 on midazolam Pharmacokinetics (PK) in healthy participants.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Neu-Ulm, 89231, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive single oral dose of midazolam on Days 1, 3 and 13 under fed conditions.
Participants will receive multiple oral doses (twice daily) of M2951 on Day 3 to Day 13 under fed conditions.
Other names: MSC2364447C, Evobrutinib
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Time frame: Up to Day 14
Time frame: Up to Day 14
Time frame: Up to Day 14
Number of participants with clinically significant change from baseline in laboratory parameters, vital signs and 12- lead ECG findings will be reported.
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Industry
A Phase I, Single-Sequence, Open-Label, Single- and Multiple-Dose Study of the Effect of Evobrutinib on Midazolam Pharmacokinetics in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06683612
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
London, United Kingdom
View Trial DetailsNCT06491979
Autoimmune Diseases, Eye Diseases
Tianjin, Tianjin Municipality, China
View Trial DetailsNCT01583530
Autoimmune Diseases, Connective Tissue Diseases
Daytona Beach, Florida, United States
View Trial DetailsNCT07284797
Arthritis, Arthritis, Rheumatoid
Melbourne, Australia
View Trial Details