Nemtabrutinib in people with severe kidney disease and healthy volunteers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study investigates the pharmacokinetics of nemtabrutinib in adults with severe renal impairment compared with healthy participants. It is an interventional Phase 1 trial that uses a single drug administration to characterize absorption, distribution, metabolism, and excretion. The study will assess safety and tolerability alongside exposure in both cohorts, to understand how kidney function affects drug handling. Eligible participants include adults with BMI 18–40 kg/m2, with stable renal function for the RI group, or medically healthy status for controls. The trial is sponsored by Merck Sharp & Dohme LLC with a single site in Florida.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

All participants:

* Has a body mass index (BMI) ≥18.0 and ≤40.0 kg/m\^2

Participants with Severe Renal impairment (RI):

* The participant has stable renal function as determined by historical measurements.

Healthy volunteers:

* Is medically healthy with no clinically significant medical history

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Renal Impairment Participants:

* History of any illness, other than renal impairment, that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.

Healthy Matched Control Participants:

* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator

Where it's running

• Floridian Clinical Research, LLC ( Site 0001)
  Miami Lakes, Florida, United States Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nemtabrutinib Plus Brexucabtagene Autoleucel (Brexu-Cel) in Relapsed or Refractory Mantle Cell Lymphoma

  This phase 2 trial tests whether adding nemtabrutinib to brexu-cel can help people whose mantle cell lymphoma has come back or not responded to prior treatment.

  Recruiting Phase 2 Vanderbilt-Ingram Cancer Center · Nashville, Tennessee · NCT07673367

• Nemtabrutinib plus rituximab for marginal zone lymphoma

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• Nemtabrutinib and venetoclax in untreated CLL/SLL

  This phase 2 study tests whether combining nemtabrutinib with venetoclax can help people with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

  Recruiting Phase 2 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07557056

• Nemtabrutinib plus lisocabtagene maraleucel for relapsed or refractory CLL/SLL

  This will test whether adding the oral drug nemtabrutinib to lisocabtagene maraleucel (CAR T‑cell therapy) helps people with CLL/SLL that has come back or stopped responding to prior treatment.

  Recruiting Phase 2 Fred Hutchinson Cancer Center · Seattle, Washington · NCT07194980

• Nemtabrutinib plus pembrolizumab for Richter transformation (DLBCL subtype)

  This phase II trial tests whether combining nemtabrutinib and pembrolizumab can shrink tumors and help people whose chronic lymphocytic leukemia has transformed into diffuse large B‑cell lymphoma (Richter transformation).

  Recruiting Phase 2 Roswell Park Cancer Institute · Buffalo, New York · NCT06863402

• Combining nemtabrutinib and rituximab to treat mantle cell lymphoma

  This study is testing if combining two treatments, nemtabrutinib and rituximab, can help people with newly diagnosed mantle cell lymphoma feel better and live longer.

  Recruiting Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT06572618

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.