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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03436394
Other study ID # MS200527_0026
Secondary ID 2017-004102-18
Status Completed
Phase Phase 1
First received
Last updated
Start date March 21, 2018
Est. completion date February 22, 2019

Study information

Verified date May 2019
Source Merck KGaA, Darmstadt, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will investigate the PK and safety of evobrutinib in subjects with different degree of renal impairment as compared to subjects with normal renal function.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date February 22, 2019
Est. primary completion date February 22, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 79 Years
Eligibility Inclusion Criteria:

- Male and Female subjects with total body weight between 50.0 and 100.0 kilograms(kg) (inclusive) and body mass index (BMI) between 19.0 and 36.0 kg per meter square (inclusive) at the time of the screening examination

- For subjects with impaired renal function: Subjects must have an eGFR according to the Modification of diet in renal disease (MDRD) equation of less than 90 mL per minute at screening and the possibility of stratification to one of the groups and a stable renal function as defined by either: if the time interval between screening and dosing is greater than 10 days, two eGFR with the second estimate within 20% of prior value or historical records of stable function over the past 3 months if within 20 percentage of screening value and within 10 days of dosing

- Other protocol defined inclusion criteria could apply

Exclusion Criteria:

- History or presence of respiratory, gastrointestinal (including bariatric or other gastric surgeries, or other conditions that may affect drug absorption) hepatic (including hepatorenal syndrome), hematological, lymphatic, neurological (including seizures), cardiovascular (including ventricular dysfunction and congestive heart failure), psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders that may affect the safety of the subject.

- Clinical history of any autoimmune disorder

- Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to Screening, which might interfere with the objectives of the study or the study procedures

- History of any malignancy except superficial basal cell carcinoma treated for curative intent may be allowed

- Other protocol defined exclusion criteria could apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Evobrutinib
Subjects will be administered a single oral dose of evobrutinib under fasting conditions.

Locations

Country Name City State
Germany Please Contact the Merck KGaA Communication Center Darmstadt

Sponsors (1)

Lead Sponsor Collaborator
Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC 0-t) of Evobrutinib Pre-dose up to 30 hours post-dose
Primary Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Evobrutinib Pre-dose up to 30 hours post-dose
Primary Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Pre-dose up to 30 hours post-dose
Secondary Occurrences of Treatment-emergent Adverse Events (TEAEs) Day 1 up to Day 6
Secondary Number of Subjects With TEAEs According to Severity Day 1 up to Day 6
Secondary Number of Subjects With Clinically Significant Abnormalities in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings Number of subjects with clinically significant abnormalities will be reported. Day 1 up to Day 6
Secondary Time to Reach the Maximum Plasma Concentration (tmax) of Evobrutinib Pre-dose up to 30 hours post-dose
Secondary Time Prior to the First Measurable (Non-Zero) Concentration (t lag) of Evobrutinib Pre-dose up to 30 hours post-dose
Secondary Terminal Rate Constant (?z) of Evobrutinib Pre-dose up to 30 hours post-dose
Secondary Terminal Half-Life (t1/2) of Evobrutinib Pre-dose up to 30 hours post-dose
Secondary Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours After Dosing (AUC 0-24h) of Evobrutinib Pre-dose up to 24 hours post-dose
Secondary Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours After Dosing (AUC 0-8h) of Evobrutinib Pre-dose up to 8 hours post-dose
Secondary Apparent Clearance (CL/f) of Evobrutinib Pre-dose up to 30 hours post-dose
Secondary Apparent Volume of Distribution During Terminal Phase (Vz/f) of Evobrutinib Pre-dose up to 30 hours post-dose
Secondary Amount of Unchanged Drug (Evobrutinib) Excreted in Urine During Collection Interval (0-8 hours) (Ae0-8h) Pre-dose up to 8 hours post-dose
Secondary Fraction of Administered Drug (Evobrutinib) Excreted in Urine (fe) Pre-dose up to 30 hours post-dose
Secondary Fraction of Unbound Drug (Evobrutinib) in the Plasma (fu) Pre-dose up to 30 hours post-dose
Secondary Renal Clearance of Evobrutinib (CLR) Pre-dose up to 30 hours post-dose
Secondary Non-Renal Clearance of Evobrutinib (CLNonR/f) Pre-dose up to 30 hours post-dose
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