HealthyPhase 1NCT03934502

Effect of Meal Composition and Timing on Evobrutinib Bioavailability

A Phase 1 study testing Evobrutinib in people with Healthy, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will evaluate the Pharmacokinetics (PK) of the Phase II tablet formulation of Evobrutinib under fasted conditions, within 30 minutes after start of a light meal, one hour prior to start of a low-fat meal, and 2 hours after start of a low-fat meal. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy 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: 20 participants
Where: 1 siteGermany
Study dates: 15 Apr 2019to 12 Jun 2019
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants are overtly healthy as medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
Participants are stable non-smokers for at least 3 months preceding screening
Male or female participants agree to be consistent with local regulations on contraception methods
Female participants are not pregnant or breastfeeding, and at least one of the following condition applies:
Not a woman of childbearing potential (WOCBP) or
If a WOCBP, use a highly effective contraceptive method (that is, with a failure rate of less than (<) 1 percent per year, preferably with low user dependency for the following time period:

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Before the first dose of the study intervention, if using hormonal contraception:
Has completed at least one 4-week cycle of an oral contraception pill and either had or has begun her menses or
Has used a depot contraceptive or extended-cycle oral contraceptive for least 28 days and has a documented negative pregnancy test using a highly sensitive assay and
A barrier method
During the intervention period
After the study intervention period (that is after the last dose of study intervention is administered) for at least 90 days, plus 30 days (a menstrual cycle) after the last dose of study intervention and agree not to donate eggs (ova, oocytes) for reproduction during this period. The Investigator evaluates the effectiveness of the contraceptive method in relationship to the first dose of study intervention
Females have a negative serum pregnancy test at the Screening Visit and within 24 hours before the first dose of study intervention If a urine test cannot be confirmed as negative (example: an ambiguous result), a serum pregnancy test is required
The Investigator reviews the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a female with an early undetected pregnancy
Male participants should agree to the following during the study intervention period and for at least 3 months
after the last dose of study intervention:
Refrain from donating sperm,
plus either:
Abstain from intercourse with a female, Or
use a male condom:
When having sexual intercourse with a WOCBP, who is not currently pregnant, and advise her to use a highly effective contraceptive method with a failure rate of <1 percent per year, since a condom may break or leak
Other protocol defined inclusion criteria could apply

Who cannot join

History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to screening
History of any malignancy
History of chronic or recurrent acute infection or any bacterial, viral, parasitic or fungal infections within 30 days prior to screening and at any time between screening and admission, or hospitalization due to infection within 6 months prior to screening
History of shingles within 12 months prior to screening
History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients

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History of alcoholism or drug abuse within 2 years prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during screening
History of residential exposure to tuberculosis, or a positive QuantiFERON® test within 4 weeks prior to screening
Administration of live vaccines or live-attenuated virus vaccines within 3 months prior to screening
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
Other protocol defined exclusion criteria could apply

Trial locations and contacts

1 site in 1 country.

Germany1 site

Nuvisan GmbH
Neu-Ulm, 89231

Other trials in Germany

About this study

Official title: Phase I, Open-Label, Randomized, Single-Dose, Four-Period, Four-Sequence Crossover Study to Compare the Effects of a Light Meal and of a Low-Fat Meal Timing on Evobrutinib Bioavailability in Healthy Volunteers

Conditions: Healthy
Being tested: Evobrutinib
Keywords: Evobrutinib, Pharmacokinetics

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 single oral dose of evobrutinib either after an overnight fast of at least 10 hours (Treatment A), within 30 minutes after start of a light meal (Treatment B), 1 hour prior to a low-fat meal (Treatment C), or 2 hours after start of a low-fat meal (Treatment D).

Study groups in NCT03934502
Study group	Role	What they receive
Evobrutinib: Treatment Sequence A, B, C, D	Experimental	Participant will receive single oral dose of evobrutinib after an overnight fast of at least 10 hours (Treatment A) for 3 days, followed by within 30 minutes after start of a light meal (Treatment B) for 2 days, followed by 1 hour prior to a low-fat meal (Treatment C) for 2 days, followed by 2 hours after start of low-fat meal (Treatment D) for 2 days. There will be 48 hours washout period between each treatment period. Receives: Drug: Evobrutinib
Evobrutinib: Treatment Sequence B, D, A, C	Experimental	Participant will receive single oral dose of evobrutinib within 30 minutes after start of a light meal (Treatment B) for 3 days, followed by 2 hours after start of a low-fat meal (Treatment D) for 2 days, followed by after an oversight fast of at least 10 hours (Treatment A) for 2 days, followed by 1 hour prior to a low-fat meal (Treatment C) for 2 days. There will be 48 hours washout period between each treatment period. Receives: Drug: Evobrutinib
Evobrutinib: Treatment Sequence C, A, D, B	Experimental	Participant will receive single oral dose of evobrutinib 1 hour prior to a low-fat meal (Treatment C) for 3 days, followed by after an oversight fast of at least 10 hours (Treatment A) for 2 days, followed by 2 hours after start of a low-fat meal (Treatment D) for 2 days followed by within 30 minutes after start of a light meal (Treatment B) for 2 days. There will be 48 hours washout period between each treatment period. Receives: Drug: Evobrutinib
Evobrutinib: Treatment Sequence D, C, B, A	Experimental	Participant will receive single oral dose of evobrutinib 2 hours after start of a low-fat meal (Treatment D) for 3 days, followed by 1 hour prior to a low-fat meal (Treatment C) for 2 days, followed by within 30 minutes after start of a light meal (Treatment B) for 2 days, followed by after an overnight fast of at least 10 hours (Treatment A) for 2 days. There will be 48 hours washout period between each treatment period. Receives: Drug: Evobrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose
Maximum Plasma Concentration Observed (Cmax) of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose

Secondary outcomes (9)

Number of Participants With Treatment -Emergent Adverse Events (TEAEs)
Measured: Day 1 up to Day 9
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings
Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported
Measured: Day 1 up to Day 9
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 24 Hours After Drug Administration (AUC0-24) of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose
Area Under The Concentration-Time Curve from Time Zero to Time 12 Hours (AUC0-12) of Evobrutinib
Measured: Pre-dose up to 12 Hours post-dose
Time to Reach Maximum Concentration (Tmax) of Evobrutinib in Plasma
Measured: Pre-dose up to 24 hours post-dose
Time Prior to the First Measurable (non-zero) Concentration of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose
Apparent Elimination Half Life (t1/2) of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose
Apparent Clearance (CL/f) of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose
Apparent Volume of Distribution During Terminal Phase (VZ/f) of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 201912 Jun 2019

First posted2 May 2019
Study start15 Apr 2019
Primary completion12 Jun 2019
Study completion12 Jun 2019

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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03934502
Sponsor's protocol ID: MS200527_0072
Other IDs: 2019-000877-21, 2019
Status last verified: Jul 2020
First submitted: 29 Apr 2019
Last updated: 7 Jul 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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, Randomized, Single-Dose, Four-Period, Four-Sequence Crossover Study to Compare the Effects of a Light Meal and of a Low-Fat Meal Timing on Evobrutinib Bioavailability in Healthy Volunteers
ClinicalTrials.gov ID: NCT03934502
Acronym / sponsor ID: MS200527_0072
Conditions: Healthy
Keywords: Evobrutinib, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Study start: 15 Apr 2019 (actual)
Primary completion: 12 Jun 2019 (actual)
Study completion: 12 Jun 2019 (actual)
First posted: 2 May 2019 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Evobrutinib: Treatment Sequence A, B, C, D	Experimental	Drug: EvobrutinibParticipant will receive single oral dose of evobrutinib after an overnight fast of at least 10 hours (Treatment A) for 3 days, followed by within 30 minutes after start of a light meal (Treatment B) for 2 days, followed by 1 hour prior to a low-fat meal (Treatment C) for 2 days, followed by 2 hours after start of low-fat meal (Treatment D) for 2 days. There will be 48 hours washout period between each treatment period.
Evobrutinib: Treatment Sequence B, D, A, C	Experimental	Drug: EvobrutinibParticipant will receive single oral dose of evobrutinib within 30 minutes after start of a light meal (Treatment B) for 3 days, followed by 2 hours after start of a low-fat meal (Treatment D) for 2 days, followed by after an oversight fast of at least 10 hours (Treatment A) for 2 days, followed by 1 hour prior to a low-fat meal (Treatment C) for 2 days. There will be 48 hours washout period between each treatment period.
Evobrutinib: Treatment Sequence C, A, D, B	Experimental	Drug: EvobrutinibParticipant will receive single oral dose of evobrutinib 1 hour prior to a low-fat meal (Treatment C) for 3 days, followed by after an oversight fast of at least 10 hours (Treatment A) for 2 days, followed by 2 hours after start of a low-fat meal (Treatment D) for 2 days followed by within 30 minutes after start of a light meal (Treatment B) for 2 days. There will be 48 hours washout period between each treatment period.
Evobrutinib: Treatment Sequence D, C, B, A	Experimental	Drug: EvobrutinibParticipant will receive single oral dose of evobrutinib 2 hours after start of a low-fat meal (Treatment D) for 3 days, followed by 1 hour prior to a low-fat meal (Treatment C) for 2 days, followed by within 30 minutes after start of a light meal (Treatment B) for 2 days, followed by after an overnight fast of at least 10 hours (Treatment A) for 2 days. There will be 48 hours washout period between each treatment period.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (22 listed)

Participants are overtly healthy as medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring
Participants are stable non-smokers for at least 3 months preceding screening
Male or female participants agree to be consistent with local regulations on contraception methods
Female participants are not pregnant or breastfeeding, and at least one of the following condition applies:
Not a woman of childbearing potential (WOCBP) or

Key exclusion criteria (11 listed)

History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to screening
History of any malignancy
History of chronic or recurrent acute infection or any bacterial, viral, parasitic or fungal infections within 30 days prior to screening and at any time between screening and admission, or hospitalization due to infection within 6 months prior to screening
History of shingles within 12 months prior to screening

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 single oral dose of evobrutinib either after an overnight fast of at least 10 hours (Treatment A), within 30 minutes after start of a light meal (Treatment B), 1 hour prior to a low-fat meal (Treatment C), or 2 hours after start of a low-fat meal (Treatment D).	Drug	Evobrutinib: Treatment Sequence A, B, C, D, Evobrutinib: Treatment Sequence B, D, A, C, Evobrutinib: Treatment Sequence C, A, D, B, Evobrutinib: Treatment Sequence D, C, B, A

Primary outcome

Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose
Maximum Plasma Concentration Observed (Cmax) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose

9 secondary outcomes

Number of Participants With Treatment -Emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 9
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings
Time frame: Day 1 up to Day 9
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 24 Hours After Drug Administration (AUC0-24) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose
Area Under The Concentration-Time Curve from Time Zero to Time 12 Hours (AUC0-12) of Evobrutinib
Time frame: Pre-dose up to 12 Hours post-dose
Time to Reach Maximum Concentration (Tmax) of Evobrutinib in Plasma
Time frame: Pre-dose up to 24 hours post-dose
Time Prior to the First Measurable (non-zero) Concentration of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose
Apparent Elimination Half Life (t1/2) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose
Apparent Clearance (CL/f) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose
Apparent Volume of Distribution During Terminal Phase (VZ/f) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose

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.
Individual participant dataSharing planned: No. Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

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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 Healthcare KGaA, Darmstadt, Germany, an affiliate of 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 Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Germany.

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 22 inclusion and 11 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 Germany. 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?

Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Evobrutinib (time frame: Pre-dose up to 24 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03934502.

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.