Please Contact the Merck KGaA Communication Center
Darmstadt, 64293, Germany
NCT Number: NCT03436394
The study will investigate the PK and safety of evobrutinib in subjects with different degree of renal impairment as compared to subjects with normal renal function.
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Notify Me18 year–79 year
All sexes
Interventional
Phase 1
Darmstadt, 64293, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be administered a single oral dose of evobrutinib under fasting conditions.
Other names: MSC2364447C, M2951
Time frame: Pre-dose up to 30 hours post-dose
Time frame: Pre-dose up to 30 hours post-dose
Time frame: Pre-dose up to 30 hours post-dose
Time frame: Day 1 up to Day 6
Time frame: Day 1 up to Day 6
Time frame: Day 1 up to Day 6
Number of subjects with clinically significant abnormalities will be reported.
Time frame: Pre-dose up to 30 hours post-dose
Time frame: Pre-dose up to 30 hours post-dose
Time frame: Pre-dose up to 30 hours post-dose
Time frame: Pre-dose up to 30 hours post-dose
Time frame: Pre-dose up to 24 hours post-dose
Time frame: Pre-dose up to 8 hours post-dose
Time frame: Pre-dose up to 30 hours post-dose
Time frame: Pre-dose up to 30 hours post-dose
Time frame: Pre-dose up to 8 hours post-dose
Time frame: Pre-dose up to 30 hours post-dose
Time frame: Pre-dose up to 30 hours post-dose
Time frame: Pre-dose up to 30 hours post-dose
Time frame: Pre-dose up to 30 hours post-dose
Merck KGaA, Darmstadt, Germany
Industry
Phase I, Open-label, Single Dose Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics (PK) of Evobrutinib (M2951) Compared to Normal Renal Function in Male and Female Subjects
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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.
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