HealthyPhase 1NCT04314024

Relative Bioavailability (rBA) of Evobrutinib Intended Commercial and Clinical Tablets, and Effect of Food on Intended Commercial Tablets

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

The study will evaluate the relative bioavailability (rBA) of the intended commercial tablet formulation (Test Treatment, TF2) of Evobrutinib compared to the clinical tablet formulation (Reference Treatment, TF1) of Evobrutinib and to assess the effect of food on the bioavailability of the intended commercial tablet… 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: 18 participants
Where: 1 siteGermany
Study dates: 25 May 2020to 23 Jun 2020
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 no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion
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 WOCBP or
If a WOCBP, use a highly effective contraceptive method (that is, with a failure rate of <1 percent per year, preferably with low user dependency for the following time period:
Before the first dose of the study intervention, if using hormonal contraception:

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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
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
Participants are stable non-smokers for at least 3 months preceding screening
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 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

Show all 11Show fewer

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

Other trials in Germany

About this study

Official title: Phase I, Randomized, Open-Label, Single-Dose, Three Period, Six-Sequence Crossover Study to Determine the Relative Bioavailability of the Evobrutinib Intended Commercial Tablet Formulation (TF2) Compared to the Clinical Tablet Formulation (TF1) and Evaluate the Effect of Food on TF2 Bioavailability in Healthy Participants

Conditions: Healthy
Being tested: Evobrutinib
Keywords: Evobrutinib, Pharmacokinetics, Relative Bioavailability, Crossover

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 and Treatment B), or under fed conditions that is within 30 minutes after start of high-fat meal (Treatment C) in period 1, 2 and 3.

Study groups in NCT04314024
Study group	Role	What they receive
Evobrutinib: Treatment Sequence 1: A-B-C	Experimental	Participants will receive single oral dose of TF1 (Treatment A) evobrutinib on Day 1 under fasted condition in period 1, followed by single oral dose of TF2 (Treatment B) on Day 3 under fasted condition in period 2, followed by TF2 (Treatment C) on Day 5 under fed condition in period 3. There will be 48 hours washout period between each treatment period. Receives: Drug: Evobrutinib
Evobrutinib: Treatment Sequence 2: A-C-B	Experimental	Participants will receive single oral dose of TF1 (Treatment A) evobrutinib on Day 1 under fasted condition in period 1, followed by TF2 (Treatment C) on Day 3 under fed condition in period 2, followed by single oral dose of TF2 (Treatment B) on Day 5 under fasted condition in period 3. There will be 48 hours washout period between each treatment period. Receives: Drug: Evobrutinib
Evobrutinib: Treatment Sequence 3: B-A-C	Experimental	Participants will receive single oral dose of TF2 (Treatment B) on Day 1 under fasted condition in period 1, followed by single oral dose of TF1 (Treatment A) evobrutinib on Day 3 under fasted condition in period 2, followed by TF2 (Treatment C) on Day 5 under fed condition in period 3. There will be 48 hours washout period between each treatment period. Receives: Drug: Evobrutinib
Evobrutinib: Treatment Sequence 4: B-C-A	Experimental	Participants will receive single oral dose of TF2 (Treatment B) on Day 1 under fasted condition in period 1, followed by TF2 (Treatment C) on Day 3 under fed condition in period 2, followed by single oral dose of TF1 (Treatment A) evobrutinib on Day 5 under fasted condition in period 3. There will be 48 hours washout period between each treatment period. Receives: Drug: Evobrutinib
Evobrutinib: Treatment Sequence 5: C-A-B	Experimental	Participants will receive single oral dose of TF2 (Treatment C) on Day 1 under fed condition in period 1, followed by single oral dose of TF1 (Treatment A) evobrutinib on Day 3 under fasted condition in period 2, followed by single oral dose of TF2 (Treatment B) on Day 5 under fasted condition in period 3. There will be 48 hours washout period between each treatment period. Receives: Drug: Evobrutinib
Evobrutinib: Treatment Sequence 6: C-B-A	Experimental	Participants will receive single oral dose of TF2 (Treatment C) on Day 1 under fed condition in period 1, followed by single oral dose of TF2 (Treatment B) on Day 3 under fasted condition in period 2, followed by single oral dose of TF1 (Treatment A) evobrutinib on Day 5 under fasted condition in period 3. 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 Under Fasted Conditions
Measured: Pre-dose up to 24 hours post-dose on Day 6
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Evobrutinib Under Fasted Conditions
Measured: Pre-dose up to 24 hours post-dose on Day 6
Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Under Fasted Conditions
Measured: Pre-dose up to 24 hours post-dose on Day 6
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Evobrutinib Under Fed Conditions
Measured: Pre-dose up to 24 hours post-dose on Day 6
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Evobrutinib Under Fed Conditions
Measured: Pre-dose up to 24 hours post-dose on Day 6
Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Under Fed Conditions
Measured: Pre-dose up to 24 hours post-dose on Day 6

Secondary outcomes (11)

Number of Participants With Treatment -Emergent Adverse Events (TEAEs) Based on Severity Under Fasted Conditions
Measured: Day 1 up to Day 6
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings Under Fasted Conditions
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 6
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 24 Hours After Evobrutinib Administration (AUC0-24)
Measured: Pre-dose up to 24 hours post-dose on Day 6
Area Under The Plasma Concentration-Time Curve From Time Zero to Time 12 Hours After Evobrutinib Administration (AUC0-12)
Measured: Pre-dose up to 12 hours post-dose on Day 6
Time to Reach Maximum Plasma Concentration (Tmax) of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose on Day 6
Time Prior to the First Measurable (non-zero) Concentration (t lag) of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose on Day 6
Terminal First Order (elimination) Rate Constant (λz) of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose on Day 6
Apparent Elimination Half Life (t1/2) of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose on Day 6
Apparent Total Body Clearance (CL/f) of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose on Day 6
Apparent Volume of Distribution During Terminal Phase (VZ/f) of Evobrutinib
Measured: Pre-dose up to 24 hours post-dose on Day 6
Relative Bioavailability of Test Treatment in Relation to Reference Treatment (Frel)
Measured: Pre-dose up to 24 hours post-dose on Day 6

Timeline

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

25 May 202023 Jun 2020

First posted18 Mar 2020
Study start25 May 2020
Primary completion23 Jun 2020
Study completion23 Jun 2020

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: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04314024
Sponsor's protocol ID: MS200527_0077
Other IDs: 2019-004738-40, 2019
Status last verified: Jul 2020
First submitted: 17 Mar 2020
Last updated: 10 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?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I, Randomized, Open-Label, Single-Dose, Three Period, Six-Sequence Crossover Study to Determine the Relative Bioavailability of the Evobrutinib Intended Commercial Tablet Formulation (TF2) Compared to the Clinical Tablet Formulation (TF1) and Evaluate the Effect of Food on TF2 Bioavailability in Healthy Participants
ClinicalTrials.gov ID: NCT04314024
Acronym / sponsor ID: MS200527_0077
Conditions: Healthy
Keywords: Evobrutinib, Pharmacokinetics, Relative Bioavailability, Crossover
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Study start: 25 May 2020 (actual)
Primary completion: 23 Jun 2020 (actual)
Study completion: 23 Jun 2020 (actual)
First posted: 18 Mar 2020 (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: 6

Arm	Type	Receives
Evobrutinib: Treatment Sequence 1: A-B-C	Experimental	Drug: EvobrutinibParticipants will receive single oral dose of TF1 (Treatment A) evobrutinib on Day 1 under fasted condition in period 1, followed by single oral dose of TF2 (Treatment B) on Day 3 under fasted condition in period 2, followed by TF2 (Treatment C) on Day 5 under fed condition in period 3. There will be 48 hours washout period between each treatment period.
Evobrutinib: Treatment Sequence 2: A-C-B	Experimental	Drug: EvobrutinibParticipants will receive single oral dose of TF1 (Treatment A) evobrutinib on Day 1 under fasted condition in period 1, followed by TF2 (Treatment C) on Day 3 under fed condition in period 2, followed by single oral dose of TF2 (Treatment B) on Day 5 under fasted condition in period 3. There will be 48 hours washout period between each treatment period.
Evobrutinib: Treatment Sequence 3: B-A-C	Experimental	Drug: EvobrutinibParticipants will receive single oral dose of TF2 (Treatment B) on Day 1 under fasted condition in period 1, followed by single oral dose of TF1 (Treatment A) evobrutinib on Day 3 under fasted condition in period 2, followed by TF2 (Treatment C) on Day 5 under fed condition in period 3. There will be 48 hours washout period between each treatment period.
Evobrutinib: Treatment Sequence 4: B-C-A	Experimental	Drug: EvobrutinibParticipants will receive single oral dose of TF2 (Treatment B) on Day 1 under fasted condition in period 1, followed by TF2 (Treatment C) on Day 3 under fed condition in period 2, followed by single oral dose of TF1 (Treatment A) evobrutinib on Day 5 under fasted condition in period 3. There will be 48 hours washout period between each treatment period.
Evobrutinib: Treatment Sequence 5: C-A-B	Experimental	Drug: EvobrutinibParticipants will receive single oral dose of TF2 (Treatment C) on Day 1 under fed condition in period 1, followed by single oral dose of TF1 (Treatment A) evobrutinib on Day 3 under fasted condition in period 2, followed by single oral dose of TF2 (Treatment B) on Day 5 under fasted condition in period 3. There will be 48 hours washout period between each treatment period.
Evobrutinib: Treatment Sequence 6: C-B-A	Experimental	Drug: EvobrutinibParticipants will receive single oral dose of TF2 (Treatment C) on Day 1 under fed condition in period 1, followed by single oral dose of TF2 (Treatment B) on Day 3 under fasted condition in period 2, followed by single oral dose of TF1 (Treatment A) evobrutinib on Day 5 under fasted condition in period 3. 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 (15 listed)

Participants are overtly healthy as medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion
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 WOCBP or
If a WOCBP, use a highly effective contraceptive method (that is, with a failure rate of <1 percent per year, preferably with low user dependency for the following time period:

Key exclusion criteria (11 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 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 and Treatment B), or under fed conditions that is within 30 minutes after start of high-fat meal (Treatment C) in period 1, 2 and 3.	Drug	Evobrutinib: Treatment Sequence 1: A-B-C, Evobrutinib: Treatment Sequence 2: A-C-B, Evobrutinib: Treatment Sequence 3: B-A-C, Evobrutinib: Treatment Sequence 4: B-C-A, Evobrutinib: Treatment Sequence 5: C-A-B, Evobrutinib: Treatment Sequence 6: 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 Under Fasted Conditions
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Evobrutinib Under Fasted Conditions
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Under Fasted Conditions
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Evobrutinib Under Fed Conditions
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Evobrutinib Under Fed Conditions
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Under Fed Conditions
Time frame: Pre-dose up to 24 hours post-dose on Day 6

11 secondary outcomes

Number of Participants With Treatment -Emergent Adverse Events (TEAEs) Based on Severity Under Fasted Conditions
Time frame: Day 1 up to Day 6
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings Under Fasted Conditions
Time frame: Day 1 up to Day 6
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 24 Hours After Evobrutinib Administration (AUC0-24)
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Area Under The Plasma Concentration-Time Curve From Time Zero to Time 12 Hours After Evobrutinib Administration (AUC0-12)
Time frame: Pre-dose up to 12 hours post-dose on Day 6
Time to Reach Maximum Plasma Concentration (Tmax) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Time Prior to the First Measurable (non-zero) Concentration (t lag) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Terminal First Order (elimination) Rate Constant (λz) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Apparent Elimination Half Life (t1/2) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Apparent Total Body Clearance (CL/f) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Apparent Volume of Distribution During Terminal Phase (VZ/f) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Relative Bioavailability of Test Treatment in Relation to Reference Treatment (Frel)
Time frame: Pre-dose up to 24 hours post-dose on Day 6

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 10 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 15 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 10 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 Under Fasted Conditions (time frame: Pre-dose up to 24 hours post-dose on Day 6). The study lists 6 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 NCT04314024.

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 10 Jul 2020.