Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib

NCT ID: NCT03725072

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-30
• Study Completion Date: 2018-12-05

Brief Summary

The purpose of the study is to determine the absorption, metabolism, and excretion of [14C]-evobrutinib in healthy participants

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Evobrutinib

Group Type: EXPERIMENTAL

Evobrutinib

Intervention Type: DRUG

Participants will receive a single, oral dose of evobrutinib under fasting conditions as a solution, which will contain \[14C\]-evobrutinib.

Interventions

Evobrutinib

Participants will receive a single, oral dose of evobrutinib under fasting conditions as a solution, which will contain \[14C\]-evobrutinib.

Intervention Type: DRUG

Other Intervention Names

M2951

Eligibility Criteria

Inclusion Criteria

• Participants are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
• Have a body weight within 50.0 to 120.0 kilogram (kg) (inclusive) and body mass index within the range 19.0 - 30.0 kilogram per meter square (kg/m^2) (inclusive)
• Male participants agree to be consistent with local regulations on contraception methods
• Can give signed informed consent

Exclusion Criteria

• History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders
• Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery
• Any surgical or medical condition which might significantly alter the ADME of drugs
• History of any malignancy, chronic or recurrent acute infection
• History of shingles
• History of drug hypersensitivity ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients
• History of alcoholism or drug abuse
• History of residential exposure to tuberculosis, or a positive QuantiFERON test at screening
• Administration of live vaccines or live-attenuated virus vaccines
• Any condition, including findings in the laboratory tests, medical history, or other screening assessments, that in the opinion of the Investigator constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study's objectives, conduct, or evaluation
• Prior/concomitant therapy
• Relevant radiation exposure
• Clinically relevant findings (excluding minor deviations) in biochemistry, hematology, coagulation and urinalysis
• Vital signs (pulse rate and blood pressure) outside the normal range
• Estimated Glomerular Filtration rate according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
• Semi supine systolic blood pressure (SBP) greater than (>) 140 millimeters of Mercury (mmHg) or less than (<) 90 mmHg, diastolic blood pressure (DBP) > 90 mmHg or < 45 mmHg and pulse rate >= 100 bpm or =< 40 bpm, at admission
• 12-Lead electrocardiogram (ECG) showing a QTcF > 450 millisecond (ms), PR > 215 ms, or QRS > 120 ms
• Positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV) I and II tests at screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

Locations

PRA Health Sciences

Groningen, , Netherlands

Countries

Netherlands

Related Links

https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS200527_0075

Trial Awareness and Transparency website

https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html

Medical Information Location Map - Med Info Contacts

Other Identifiers

2018-003371-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MS200527_0075

Identifier Type: -

Identifier Source: org_study_id