Effect of Hepatic Impairment on M2951 (Bruton's Tyrosine Kinase [BTK] Inhibitor) Pharmacokinetics (PK)

  • STATUS
    Recruiting
  • End date
    Jun 29, 2021
  • participants needed
    28
  • sponsor
    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Updated on 16 February 2021

Summary

This study is to investigate the PK and safety of M2951 (BTK inhibitor) in participants with different degrees of hepatic impairment compared to participants with normal hepatic function.

Details
Condition Hepatic Impairment
Treatment M2951 (BTK inhibitor)
Clinical Study IdentifierNCT04546789
SponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Last Modified on16 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 79 yrs?
Gender: Male or Female
Do you have Hepatic Impairment?
Do you have any of these conditions: Do you have Hepatic Impairment??
Do you have any of these conditions: Do you have Hepatic Impairment??
Do you have any of these conditions: Do you have Hepatic Impairment??
Do you have any of these conditions: Do you have Hepatic Impairment??
Do you have any of these conditions: Do you have Hepatic Impairment??
Do you have any of these conditions: Do you have Hepatic Impairment??
Do you have any of these conditions: Do you have Hepatic Impairment??
Participants with normal hepatic function only will be overtly healthy as determined by 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 OR
Participants with moderately impaired hepatic function only will be considered to have moderately (Child-Pugh class B and confirmed liver cirrhosis) impaired hepatic function and has been clinically stable for at least 1 month prior to Screening OR
Participants with mildly impaired hepatic function only will be considered to have mildly (Child-Pugh class A and confirmed liver cirrhosis) impaired hepatic function and has been clinically stable for at least 1 month prior to Screening
Have a body weight within 50.0 and 120.0 kilogram (kg) and body mass index (BMI) within the range 19.0 and 36.0 kilogram per square meter (kg/m^2)
Female participants are not pregnant or breastfeeding, and at least one of the following conditions applies
Not a woman of childbearing potential (WOCBP)
Other protocol defined inclusion criteria could apply

Exclusion Criteria

Clinical history of autoimmune disorder with hepatic influence (Hashimoto thyroiditis and rheumatic diseases allowed)
History of any malignancy
Diseases and surgeries of the gastrointestinal tract, which could influence the gastrointestinal anatomy and mobility. Prior history of cholecystectomy or inflammatory bowel disease, and any clinically relevant surgery within 6 months prior to Screening
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; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the trial per the Investigator's discretion
Participants with impaired hepatic function will be excluded who had Primary and secondary biliary cirrhosis
Participants with impaired hepatic function will be excluded with Clinical evidence of severe ascites
Participants with impaired hepatic function will be excluded with Hepatic encephalopathy Grade greater than 1
Other protocol defined exclusion criteria could apply
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