HealthyPhase 1NCT03725072
Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib
A Phase 1 study testing Evobrutinib in people with Healthy, run by Merck KGaA, Darmstadt, Germany at 1 site in Netherlands.
Trial summary
The purpose of the study is to determine the absorption, metabolism, and excretion of [14C]-evobrutinib in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Evobrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Oct 2018to 5 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Other protocol defined inclusion criteria could apply
Who cannot join
- 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
Show all 19Show fewer
- 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
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I, Open Label, Single Dose Study to Determine the Pharmacokinetics, Metabolism, and Excretion of [14C]-Evobrutinib in Healthy Participants
The purpose of the study is to determine the absorption, metabolism, and excretion of [14C]-evobrutinib in healthy participants
- Conditions
- Healthy
- Being tested
- Evobrutinib
- Keywords
- [14C]-evobrutinib, Healthy, Pharmacokinetics, Metabolism, Excretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvobrutinibDrug
Also called M2951
Participants will receive a single, oral dose of evobrutinib under fasting conditions as a solution, which will contain [14C]-evobrutinib.
| Study group | Role | What they receive |
|---|---|---|
| Evobrutinib | Experimental | Not described Receives: Drug: Evobrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Radioactivity Recovery Rate of Evobrutinib, Total Radioactivity and its Metabolites
Measured: Pre-dose up to Day 35 post-dose
Percentage Excretion of Evobrutinib, Total Radioactivity and its Metabolites in Urine and Feces
Measured: Pre-dose up to Day 35 post-dose
Renal Clearance of Evobrutinib, Total Radioactivity and its Metabolites
Measured: Pre-dose up to Day 35 post-dose
Maximum Observed Plasma Concentration (Cmax) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
Measured: Pre-dose up to Day 35 post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
Measured: Pre-dose up to Day 35 post-dose
Terminal Elimination Half-Life (t1/2) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
Measured: Pre-dose up to Day 35 post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
Measured: Pre-dose up to Day 35 post-dose
Maximum Observed Plasma Concentration (Cmax) of Evobrutinib
Measured: Pre-dose up to Day 35 post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Evobrutinib
Measured: Pre-dose up to Day 35 post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Evobrutinib
Measured: Pre-dose up to Day 35 post-dose
Terminal Elimination Half-Life (t1/2) of Evobrutinib
Measured: Pre-dose up to Day 35 post-dose
Apparent Volume of Distribution During Terminal Phase (Vz/f) of Evobrutinib
Measured: Pre-dose up to Day 35 post-dose
Apparent Clearance (CL/f) of Evobrutinib
Measured: Pre-dose up to Day 35 post-dose
Secondary outcomes (3)
Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings
Number of participants with clinically significant abnormalities will be reported.
Measured: From time of first dose to end of study participation approximately at Day 37
Occurrence of Treatment -emergent Adverse Events (TEAEs) and Serious TEAEs
Measured: From time of first dose to end of study participation approximately at Day 37
Occurrence of Treatment -emergent Adverse Events (TEAEs) and Serious TEAEs by Severity
Measured: From time of first dose to end of study participation approximately at Day 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start30 Oct 2018
- Primary completion5 Dec 2018
- Study completion5 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725072
- Sponsor's protocol ID
- MS200527_0075
- Other IDs
- 2018-003371-35, 2018
- Status last verified
- Jul 2020
- First submitted
- 29 Oct 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open Label, Single Dose Study to Determine the Pharmacokinetics, Metabolism, and Excretion of [14C]-Evobrutinib in Healthy Participants
- ClinicalTrials.gov ID
- NCT03725072
- Acronym / sponsor ID
- MS200527_0075
- Conditions
- Healthy
- Keywords
- [14C]-evobrutinib, Healthy, Pharmacokinetics, Metabolism, Excretion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the absorption, metabolism, and excretion of [14C]-evobrutinib in healthy participants
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evobrutinib | Experimental | Drug: Evobrutinib |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- Other protocol defined inclusion criteria could apply
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvobrutinibAlso: M2951Participants will receive a single, oral dose of evobrutinib under fasting conditions as a solution, which will contain [14C]-evobrutinib. | Drug | Evobrutinib |
Primary outcome
Total Radioactivity Recovery Rate of Evobrutinib, Total Radioactivity and its Metabolites
Time frame: Pre-dose up to Day 35 post-dose
Percentage Excretion of Evobrutinib, Total Radioactivity and its Metabolites in Urine and Feces
Time frame: Pre-dose up to Day 35 post-dose
Renal Clearance of Evobrutinib, Total Radioactivity and its Metabolites
Time frame: Pre-dose up to Day 35 post-dose
Maximum Observed Plasma Concentration (Cmax) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
Time frame: Pre-dose up to Day 35 post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
Time frame: Pre-dose up to Day 35 post-dose
Terminal Elimination Half-Life (t1/2) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
Time frame: Pre-dose up to Day 35 post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Total [14C] Radioactivity (Evobrutinib and Metabolites)
Time frame: Pre-dose up to Day 35 post-dose
Maximum Observed Plasma Concentration (Cmax) of Evobrutinib
Time frame: Pre-dose up to Day 35 post-dose
Time to Reach Maximum Plasma Concentration (Tmax) of Evobrutinib
Time frame: Pre-dose up to Day 35 post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Evobrutinib
Time frame: Pre-dose up to Day 35 post-dose
Terminal Elimination Half-Life (t1/2) of Evobrutinib
Time frame: Pre-dose up to Day 35 post-dose
Apparent Volume of Distribution During Terminal Phase (Vz/f) of Evobrutinib
Time frame: Pre-dose up to Day 35 post-dose
Apparent Clearance (CL/f) of Evobrutinib
Time frame: Pre-dose up to Day 35 post-dose
3 secondary outcomes
Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings
Time frame: From time of first dose to end of study participation approximately at Day 37
Occurrence of Treatment -emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From time of first dose to end of study participation approximately at Day 37
Occurrence of Treatment -emergent Adverse Events (TEAEs) and Serious TEAEs by Severity
Time frame: From time of first dose to end of study participation approximately at Day 37
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Evobrutinib in people with Healthy, run by Merck KGaA, Darmstadt, Germany at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Radioactivity Recovery Rate of Evobrutinib, Total Radioactivity and its Metabolites (time frame: Pre-dose up to Day 35 post-dose). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.