Status:
COMPLETED
Study Comparing Pharmacokinetics of Different Formulations of Evobrutinib in Healthy Participants
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), and safety and tolerability of evobrutinib after oral administration of immediate release (IR) and modified rel...
Eligibility Criteria
Inclusion
- Participants are overtly healthy as determined by medical evaluation, including comprehensive clinical assessment (detailed medical history and a complete physical examination), ECG, and laboratory investigations (hematology and biochemistry)
- Participants have a body weight within 50.0 to 100.0 kilogram (kg) and body mass index (BMI) within the range 19 to 32 kilogram per meter square (kg/m\^2) (inclusive)
- Other protocol defined inclusion criteria could apply
Exclusion
- Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, metabolic, hematological, lymphatic, neurological (including epilepsy), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as determined by medical evaluation
- Participants with history of any malignancy
- Administration of live vaccines or live-attenuated virus vaccines within 3 months prior to Screening. Administration of other types of vaccines (e.g. SARS-CoV-2 vaccines) is allowed until 2 weeks before the admission to the CRU
- Medical history and physical examination results that include any ongoing clinically relevant findings as judged by the Investigator
- Moderate or strong inhibitors or inducers of CYP3A4/5 or Pgp within 4 weeks prior to the first administration of study intervention
- Other protocol-defined exclusion criteria could apply
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2023
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05245396
Start Date
February 2 2022
End Date
February 14 2023
Last Update
March 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quotient Clinical Ltd
Nottingham, United Kingdom, NG11